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          "en" => "<p id="spar0010" class="elsevierStyleSimplePara elsevierViewall">Data on the evolution of weight &#40;kg&#41; in six and 12 months in the three groups&#58; total group&#44; GLP-1ra naive group&#44; and GLP-1ra experienced group&#46; GLP-1ra&#58; GLP-1 receptor agonist&#46;</p>"
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    "textoCompleto" => "<span class="elsevierStyleSections"><span id="sec0005" class="elsevierStyleSection elsevierViewall"><span class="elsevierStyleSectionTitle" id="sect0065">Introduction</span><p id="par0005" class="elsevierStylePara elsevierViewall">Type 2 diabetes mellitus &#40;DM2&#41; is a slowly progressive disease&#46; On occasion&#44; due to the gradual decline in pancreatic beta cell function&#44; it is necessary to intensify the initial treatment to maintain adequate glycemic control&#46;</p><p id="par0010" class="elsevierStylePara elsevierViewall">Treatment with insulin &#40;initially mostly basal&#41; is frequently used following the failure of several oral lipid-lowering drugs maintain HbA1c at target levels<a class="elsevierStyleCrossRef" href="#bib0005"><span class="elsevierStyleSup">1</span></a>&#46; However&#44; data published in various randomized clinical trials &#40;RCTs&#41;<a class="elsevierStyleCrossRefs" href="#bib0010"><span class="elsevierStyleSup">2&#44;3</span></a> and cohort studies<a class="elsevierStyleCrossRefs" href="#bib0020"><span class="elsevierStyleSup">4&#44;5</span></a> show that a significant proportion of patients who receive insulin therapy do not reach glycemic control targets either&#46;</p><p id="par0015" class="elsevierStylePara elsevierViewall">When basal insulin requirements exceed 0&#46;5&#160;IU&#47;kg of weight&#44; subsequent dose increases do not result in an improvement in glycemic control&#44; but do result in an increase in weight and hypoglycemic episodes<a class="elsevierStyleCrossRef" href="#bib0030"><span class="elsevierStyleSup">6</span></a>&#46; At present&#44; when faced with this situation&#44; the American Diabetes Association recommends associating treatment with a GLP-1 receptor agonist &#40;GLP-1ra&#41; in patients in which atherosclerotic cardiovascular disease and&#47;or obesity are predominant<a class="elsevierStyleCrossRef" href="#bib0005"><span class="elsevierStyleSup">1</span></a>&#46;</p><p id="par0020" class="elsevierStylePara elsevierViewall">The benefit of combined insulin and GLP-1ra treatment lies in the sum of their components&#8217; synergic and complementary effects<a class="elsevierStyleCrossRefs" href="#bib0035"><span class="elsevierStyleSup">7&#44;8</span></a>&#46;</p><p id="par0025" class="elsevierStylePara elsevierViewall">GLP-1ras improve insulin secretion in a glucose-dependent manner&#44; suppress glucagon secretion&#44; act on post-prandial blood glucose by slowing stomach emptying&#44; and promote weight loss&#46; All of this improves glycemic control with a low risk of hypoglycemia and weight gain<a class="elsevierStyleCrossRefs" href="#bib0035"><span class="elsevierStyleSup">7&#44;8</span></a>&#46;</p><p id="par0030" class="elsevierStylePara elsevierViewall">Semaglutide &#40;Novo Nordisk A&#47;S&#44; Denmark&#41; is a GLP-1ra&#46; To improve glycemic control in adults with DM2&#44; in addition to diet and exercise&#44; semaglutide can be administered in both subcutaneous &#40;SC&#41; formulations once per week<a class="elsevierStyleCrossRef" href="#bib0045"><span class="elsevierStyleSup">9</span></a> or oral formulations once per day<a class="elsevierStyleCrossRef" href="#bib0050"><span class="elsevierStyleSup">10</span></a>&#46;</p><p id="par0035" class="elsevierStylePara elsevierViewall">In the SUSTAIN clinical trials&#44; semaglutide SC was demonstrated to be superior by reducing HbA1c and body weight compared to the placebo and a wide variety of active comparators&#44; including SGLT-2is&#44; other GLP-1ras&#44; and insulin glargine&#44; with a safety profile similar to that of other GLP-1ras<a class="elsevierStyleCrossRefs" href="#bib0055"><span class="elsevierStyleSup">11&#8211;16</span></a>&#46;</p><p id="par0040" class="elsevierStylePara elsevierViewall">However&#44; the population represented in RCTs is not the same as patients in clinical practice&#44; given that the former must meet strict inclusion and exclusion criteria&#46; Real-world studies aim to verify the findings of these RCTs and are important for knowing the efficacy and safety of the drug in clinical practice settings&#46;</p><p id="par0045" class="elsevierStylePara elsevierViewall">Various studies have compared the combination of a GLP-1ra and insulin to an intensification of the insulin regimen<a class="elsevierStyleCrossRefs" href="#bib0085"><span class="elsevierStyleSup">17&#44;18</span></a>&#46; Meta-analyses indicate that glycemic control is similar or better with the addition of GLP-1ras with benefits over insulin intensification&#44; including a reduction in body weight and lower incidence of hypoglycemic episodes&#46;</p></span><span id="sec0010" class="elsevierStyleSection elsevierViewall"><span class="elsevierStyleSectionTitle" id="sect0070">Objectives</span><p id="par0050" class="elsevierStylePara elsevierViewall">The purpose of this study is to determine the benefits in clinical practice of starting semaglutide SC in patients who have previously been treated with subcutaneous insulin&#46;</p><p id="par0055" class="elsevierStylePara elsevierViewall">The primary objective was the change in HbA1c values at six and 12 months from the baseline value &#40;&#37;-point&#41;&#46; Secondary aims included the change in body weight &#40;kg&#41;&#44; total insulin dose &#40;IU&#41;&#44; and insulin dose per weight &#40;IU&#47;kg&#41; from baseline to the two time points&#46;</p><p id="par0060" class="elsevierStylePara elsevierViewall">In addition&#44; the study seeks to confirm the drug&#8217;s safety in this subgroup of the population with diabetes by determining the rate of treatment suspensions and patient dropouts as well as severe hypoglycemic episodes&#46;</p></span><span id="sec0015" class="elsevierStyleSection elsevierViewall"><span class="elsevierStyleSectionTitle" id="sect0075">Materials and methods</span><span id="sec0020" class="elsevierStyleSection elsevierViewall"><span class="elsevierStyleSectionTitle" id="sect0080">Study design and location</span><p id="par0065" class="elsevierStylePara elsevierViewall">This retrospective&#44; open-label&#44; 53-week&#44; observational study evaluated the real-world clinical repercussions of the addition of weekly semaglutide SC in adults with DM2 previously treated with insulin followed-up on in the Endocrinology and Nutrition Department outpatient clinic of the Central University Hospital of Asturias&#46;</p></span><span id="sec0025" class="elsevierStyleSection elsevierViewall"><span class="elsevierStyleSectionTitle" id="sect0085">Study population</span><p id="par0070" class="elsevierStylePara elsevierViewall"><span class="elsevierStyleItalic">Inclusion criteria&#58;</span> patients &#8805;18 years with DM2 with more 12 weeks since onset who were already in treatment with insulin &#40;basal&#44; basal-bolus&#44; or premixed&#41;&#46;</p><p id="par0075" class="elsevierStylePara elsevierViewall"><span class="elsevierStyleItalic">Exclusion criteria&#58;</span> treatment with any investigational drug &#40;a drug not currently approved for treatment&#41; within 90 days prior to inclusion&#44; hypersensitivity to semaglutide or any of its excipients&#44; and an estimated glomerular filtration rate &#60;15&#160;mL&#47;min&#47;1&#46;73&#160;m<span class="elsevierStyleSup">2</span> on the most recent blood test available&#46;</p><p id="par0080" class="elsevierStylePara elsevierViewall">The decision to start treatment with semaglutide SC&#44; prescribe other hypoglycemic treatments&#44; or prescribe a diet and exercise regimen was the responsibility of each physician&#46;</p><p id="par0085" class="elsevierStylePara elsevierViewall">All DPP4 inhibitor drug treatment was suspended when semaglutide was started&#46;</p><p id="par0090" class="elsevierStylePara elsevierViewall">The recruitment period was from October to December 2019&#46; The data &#40;up to January 2021&#41; were retrospectively collected by the physicians&#46;</p><p id="par0095" class="elsevierStylePara elsevierViewall">The patients started treatment with semaglutide SC in a preloaded pen according to routine clinical practice&#46; The medication was provided by the sponsor&#46; The physician determined the initial dose&#44; the escalation dose&#44; and the maintenance dose as well as any later changes to the maintenance dose&#46;</p><p id="par0100" class="elsevierStylePara elsevierViewall">After visit 1 &#40;0 weeks&#41;&#44; the patients attended visits only if appropriate according to routine clinical practice &#40;at six months and at one year from the start&#41;&#46; Given that the study took place during the COVID-19 pandemic period&#44; body measurement data are not available for all initially recruited individuals&#44; given that many of the intermediate visits were online&#46; Nevertheless&#44; we consider glycated hemoglobin values as the primordial data set as they report on the principal objective &#40;glycemic control&#41;&#46; Patients &#40;n&#160;&#61;&#160;17&#41; who did not have follow-up blood tests performed between weeks 28 and 38 were considered lost to follow-up&#46;</p><p id="par0105" class="elsevierStylePara elsevierViewall">The main study variables were quantitative&#58; HbA1c was measured using high-performance liquid chromatography &#40;HPLC&#41; &#40;Jokoh HS-10 Analyzer&#41;&#46; The initial values were standardizing according to IFCC criteria &#40;JDS&#47;JSCC HbA1c&#160;&#61;&#160;0&#46;927 &#91;IFCC HbA1c&#93;&#160;&#43;&#160;1&#46;73&#41;&#46; Height&#44; weight&#44; and BMI &#40;weight in kg divided by height in meters squared&#41; were measured with the subject wearing light clothing and without shoes&#46; Data on insulin units were gathered by the physician during the medical consultation according to data provided by the patient and subsequent prescriptions&#46;</p></span><span id="sec0030" class="elsevierStyleSection elsevierViewall"><span class="elsevierStyleSectionTitle" id="sect0090">Statistical analysis</span><p id="par0110" class="elsevierStylePara elsevierViewall">We used descriptive statistics &#40;mean&#160;&#177;&#160;standard deviation &#40;SD&#41; for quantitative variables and percentages for categorical variables&#41; to describe patients&#8217; characteristics upon starting semaglutide&#46;</p><p id="par0115" class="elsevierStylePara elsevierViewall">The baseline characteristics were analyzed in the analysis of the total group&#44; which included all patients who started treatment with semaglutide &#40;n&#160;&#61;&#160;117&#41;&#46;</p><p id="par0120" class="elsevierStylePara elsevierViewall">The primary objective &#40;change in HbA1c&#41; was calculated with 95&#37; confidence intervals and two-tailed <span class="elsevierStyleItalic">p</span> values&#46; The secondary and exploratory objectives were calculated in the same manner as the primary objective&#46;</p><p id="par0125" class="elsevierStylePara elsevierViewall">The population for the outcomes analysis was individuals who started treatment with semaglutide and who had data on HbA1c &#40;n&#160;&#61;&#160;100&#41;&#44; weight &#40;n&#160;&#61;&#160;55&#41;&#44; and insulin units &#40;n&#160;&#61;&#160;87&#41; from the end of the study&#46;</p><p id="par0130" class="elsevierStylePara elsevierViewall">The repeated measures ANOVA comparison of means test was used for the statistical analysis&#44; performed using the GraphPad program&#46;</p><p id="par0135" class="elsevierStylePara elsevierViewall">A subgroup analysis was performed based on whether the patient was already in treatment with another GLP-1ra or if it was started at that time &#40;GLP-1ra naive vs&#46; GLP-1ra experienced&#41;&#46;</p></span></span><span id="sec0035" class="elsevierStyleSection elsevierViewall"><span class="elsevierStyleSectionTitle" id="sect0095">Results</span><span id="sec0040" class="elsevierStyleSection elsevierViewall"><span class="elsevierStyleSectionTitle" id="sect0100">Patients&#8217; baseline characteristics</span><p id="par0140" class="elsevierStylePara elsevierViewall">A total of 117 patients were evaluated in the study period&#44; of which 100 &#40;85&#37;&#41; completed follow-up to week 53 &#40;<a class="elsevierStyleCrossRef" href="#tbl0005">Table 1</a>&#41;&#46; The reasons the 17 patients did not complete follow-up were&#58; lack of adherence to medical visits &#40;n&#160;&#61;&#160;9&#41;&#44; adverse effects &#40;n&#160;&#61;&#160;6&#41;&#44; and clinical decision &#40;n&#160;&#61;&#160;2&#41;&#46; The adverse effects which led to the suspension of the drug were gastrointestinal in nature &#40;nausea and vomiting&#41;&#46; The mean age of patients was 64&#46;4&#160;&#177;&#160;9&#46;4 years and 57&#37; were male&#46;</p><elsevierMultimedia ident="tbl0005"></elsevierMultimedia><p id="par0145" class="elsevierStylePara elsevierViewall">The mean baseline HbA1c was 8&#46;31&#37;&#44; the mean duration of diabetes was 16&#46;7 years&#44; and the mean body weight was 97&#46;3&#160;kg&#46;</p><p id="par0150" class="elsevierStylePara elsevierViewall">Patients were prescribed an initial dose of 0&#46;25&#160;mg of semaglutide weekly&#46; At six months from starting treatment&#44; 99 &#40;85&#37;&#41; patients were on a dose of 0&#46;5&#160;mg&#47;week&#44; 11 &#40;9&#37;&#41; were on a dose of 1&#160;mg&#47;week&#44; and 7 &#40;6&#37;&#41; continued with the initial dose of 0&#46;25&#160;mg&#47;week&#46; At the end of follow-up&#44; 55 &#40;47&#37;&#41; patients received a dose of 1&#160;mg&#47;week&#44; 39 &#40;33&#37;&#41; patients received 0&#46;5&#160;mg&#47;week&#44; and 6 &#40;5&#37;&#41; maintained the dose of 0&#46;25&#160;mg&#47;week&#46; At 12 months from starting medical treatment&#44; 6 &#40;6&#37;&#41; continued with the initial dose of 0&#46;25&#160;mg&#47;week&#44; 39 &#40;39&#37;&#41; were on 0&#46;5&#160;mg&#47;week&#44; and 55 &#40;55&#37;&#41; had progressed to the maximum dose of 1&#160;mg&#47;week&#46;</p><p id="par0155" class="elsevierStylePara elsevierViewall">Before starting treatment with semaglutide&#44; 37 &#40;32&#37;&#41; patients were in treatment with another GLP-1ra&#58; 17 patients with liraglutide&#44; 17 with dulaglutide&#44; and 7 with exenatide or lixisenatide&#46;</p><p id="par0160" class="elsevierStylePara elsevierViewall">The mean number of oral antidiabetics &#40;OAD&#41;&#47;patient&#47;day was 1&#46;6&#160;&#177;&#160;1&#46;02&#46; A total of 20 patients &#40;17&#37;&#41; were not taking any OAD&#44; 26 patients &#40;23&#37;&#41; took 1 OAD&#44; 45 &#40;39&#37;&#41; took 2 OAD&#44; 23 &#40;20&#37;&#41; took 3 OAD&#44; and 2 &#40;1&#37;&#41; took 4 OAD&#46; At the start of the study&#44; 91 &#40;78&#37;&#41; patients were taking metformin&#46;</p><p id="par0165" class="elsevierStylePara elsevierViewall">In regard to the insulin regimen prior to starting semaglutide&#44; 49 &#40;42&#37;&#41; patients were only taking basal insulin&#44; 42 &#40;36&#37;&#41; were taking basal-bolus insulin&#44; and 26 &#40;22&#37;&#41; were taking premixed insulin&#46;</p></span><span id="sec0045" class="elsevierStyleSection elsevierViewall"><span class="elsevierStyleSectionTitle" id="sect0105">HbA1c</span><p id="par0170" class="elsevierStylePara elsevierViewall">One hundred of the initial 117 patients completed the study &#40;data at baseline&#44; at six months&#44; and at one year&#41;&#46; At six months from starting weekly semaglutide SC&#44; the mean change in HbA1c was &#8211;0&#46;86&#37; &#40;95&#37; CI&#58; &#8211;0&#46;46&#59; &#8211;1&#46;15&#59; <span class="elsevierStyleItalic">p</span>&#160;&#60;&#160;0&#46;0001&#41; &#40;<a class="elsevierStyleCrossRef" href="#fig0005">Fig&#46; 1</a>&#41;&#46; At 12 months&#44; the decrease in HbA1c was maintained&#46; Therefore&#44; the mean estimated change compared to the baseline figure was &#8211;0&#46;74&#37; &#40;95&#37; CI&#58; &#8211;0&#46;59&#59; &#8211;1&#46;14&#59; <span class="elsevierStyleItalic">p</span>&#160;&#60;&#160;0&#46;0001&#41;&#46; There were no statistically significant differences between data at six and 12 months&#46;</p><elsevierMultimedia ident="fig0005"></elsevierMultimedia><p id="par0175" class="elsevierStylePara elsevierViewall">In the subgroup of GLP-1ra naive patients&#44; the change in HbA1c from the value at baseline to the value at 12 months was slightly less &#40;&#8211;0&#46;94&#37;&#59; 95&#37; CI&#58; &#8211;1&#46;36&#59; &#8211;0&#46;53&#59; <span class="elsevierStyleItalic">p</span>&#160;&#60;&#160;0&#46;0001&#41; than the change in the value at six months &#40;&#8211;1&#46;21&#37;&#41;&#46; Regarding the GLP-1ra experienced group&#44; the difference of &#8211;0&#46;44&#37; &#40;95&#37; CI&#58; &#8211;0&#46;90&#59; 0&#46;02&#59; <span class="elsevierStyleItalic">p</span>&#160;&#61;&#160;0&#46;0616&#41; at 12 months compared to the initial value was not statistically significant&#59; the value at six months was not significant either&#46;</p></span><span id="sec0050" class="elsevierStyleSection elsevierViewall"><span class="elsevierStyleSectionTitle" id="sect0110">Weight</span><p id="par0180" class="elsevierStylePara elsevierViewall">The mean baseline weight was 97&#46;3&#160;&#177;&#160;18&#46;43&#160;kg&#46; Only 55 &#40;47&#46;4&#37;&#41; patients have data available from the study&#8217;s three time points&#46; In general&#44; the mean change in body weight at six months compared to the initial value was &#8211;5&#46;33&#160;kg &#40;95&#37; CI&#58; &#8211;4&#46;25&#59; &#8211;6&#46;42&#59; <span class="elsevierStyleItalic">p</span>&#160;&#60;&#160;0&#46;0001&#41;&#46; The value at 12 months was &#8211;3&#46;61 kg &#40;95&#37; CI&#58; &#8211;2&#46;30&#59; &#8211;4&#46;92&#59; <span class="elsevierStyleItalic">p</span>&#160;&#60;&#160;0&#46;0001&#41; &#40;<a class="elsevierStyleCrossRef" href="#fig0010">Fig&#46; 2</a>&#41;&#46;</p><elsevierMultimedia ident="fig0010"></elsevierMultimedia><p id="par0185" class="elsevierStylePara elsevierViewall">In the subgroup analysis&#44; the initial baseline weight in the GLP-1ra naive group was 95&#46;54&#160;kg &#40;SD 19&#46;21&#41;&#46; At six months from starting semaglutide&#44; a mean decrease of &#8211;5&#46;68&#160;kg was achieved &#40;95&#37; CI&#58; &#8211;4&#46;57&#59; &#8211;7&#46;18&#59; <span class="elsevierStyleItalic">p</span>&#160;&#60;&#160;0&#46;0001&#41; and at 12 months&#44; a mean decrease of &#8211;4&#46;54 kg was achieved &#40;95&#37; CI&#58; &#8211;2&#46;80&#59; &#8211;6&#46;28&#59; <span class="elsevierStyleItalic">p</span>&#160;&#60;&#160;0&#46;0001&#41;&#46; However&#44; the mean baseline weight was higher in the GLP-1ra experienced group&#58; 100&#46;95 kg &#40;SD 16&#46;34&#41;&#46; At six months&#44; a reduction of &#8211;1&#46;01 kg was achieved &#40;95&#37; CI&#58; &#8211;1&#46;21&#59; 3&#46;24&#59; NS&#41; and at 12 months&#44; a reduction of &#8211;2&#46;70 kg was achieved &#40;95&#37; CI&#58; &#8211;0&#46;80&#59; &#8211;4&#46;60&#59; <span class="elsevierStyleItalic">p</span>&#160;&#61;&#160;0&#46;004&#41;&#46;</p></span><span id="sec0055" class="elsevierStyleSection elsevierViewall"><span class="elsevierStyleSectionTitle" id="sect0115">Total insulin dose</span><p id="par0190" class="elsevierStylePara elsevierViewall">The initial total insulin dose was 63&#46;78&#160;&#177;&#160;39&#46;69 IU&#46; Data are available on 87 &#40;75&#37;&#41; patients throughout the study &#40;<a class="elsevierStyleCrossRef" href="#fig0015">Fig&#46; 3</a>&#41;&#46; Compared to the initial value&#44; the mean change in the total population at six months was &#8211;15&#46;18 IU &#40;95&#37; CI&#58; &#8211;10&#46;67&#59; &#8211;19&#46;68&#59; <span class="elsevierStyleItalic">p</span>&#160;&#60;&#160;0&#46;0001&#41; and at 12 months was &#8211;15&#46;88 IU &#40;95&#37; CI&#58; &#8211;10&#46;98&#59; &#8211;20&#46;74&#59; <span class="elsevierStyleItalic">p</span>&#160;&#60;&#160;0&#46;0001&#41;&#46;</p><elsevierMultimedia ident="fig0015"></elsevierMultimedia><p id="par0195" class="elsevierStylePara elsevierViewall">In the subgroup analysis&#44; the initial total dose of insulin in the GLP-1ra naive group was 63&#46;00 &#40;SD 38&#46;64&#41;&#46; At six months from starting semaglutide&#44; a mean reduction of &#8211;18&#46;06 IU was achieved &#40;95&#37; CI&#58; &#8211;12&#46;33&#59; &#8211;23&#46;78&#59; <span class="elsevierStyleItalic">p</span>&#160;&#60;&#160;0&#46;0001&#41; and at 12 months&#44; a mean reduction of 22&#46;21 IU was achieved &#40;95&#37; CI&#58; &#8211;9&#46;32&#59; &#8211;35&#46;10&#59; <span class="elsevierStyleItalic">p</span>&#160;&#60;&#160;0&#46;0001&#41;&#46;</p><p id="par0200" class="elsevierStylePara elsevierViewall">On the contrary&#44; this decrease was less noteworthy in the GLP-1ra experienced subgroup&#46; The total initial dose was 65&#46;46 IU &#40;SD 42&#46;36&#41;&#46; At six months from starting semaglutide&#44; a mean reduction of 8&#46;99 IU was achieved &#40;95&#37; CI&#58; &#8211;2&#46;21&#59; 15&#46;77&#59; <span class="elsevierStyleItalic">p</span>&#160;&#61;&#160;0&#46;008&#41; and at 12 months&#44; a mean reduction of 4&#46;79 IU was achieved &#40;95&#37; CI&#58; &#8211;2&#46;76&#59; 12&#46;24&#59; <span class="elsevierStyleItalic">p</span>&#160;&#61;&#160;0&#46;2935&#41;&#46;</p></span><span id="sec0060" class="elsevierStyleSection elsevierViewall"><span class="elsevierStyleSectionTitle" id="sect0120">Units of insulin&#47;kg of weight</span><p id="par0205" class="elsevierStylePara elsevierViewall">Only 52 &#40;50&#37;&#41; of the 117 patients have data available on IU&#47;kg of weight from the three evaluations&#46; The mean initial figure was 0&#46;67&#160;&#177;&#160;0&#46;44 IU&#47;kg&#46; The mean change at six months compared to the initial value was &#8211;0&#46;14 IU&#47;kg &#40;95&#37; CI&#58; &#8211;0&#46;09&#59; &#8211;0&#46;20&#59; <span class="elsevierStyleItalic">p</span>&#160;&#60;&#160;0&#46;0001&#41;&#46; At 12 months from the start of the study&#44; a mean reduction of &#8211;0&#46;15 IU&#47;kg was achieved &#40;95&#37; CI&#58; &#8211;0&#46;10&#59; &#8211;0&#46;21&#59; <span class="elsevierStyleItalic">p</span>&#160;&#60;&#160;0&#46;0001&#41;&#46;</p><p id="par0210" class="elsevierStylePara elsevierViewall">In the subgroup analysis&#44; the initial figure of IU&#47;kg of weight in the GLP-1ra naive group &#40;n&#160;&#61;&#160;35&#41; was 0&#46;69 IU&#47;kg &#40;SD 0&#46;46&#41;&#46; At six months&#44; a reduction of &#8211;0&#46;19 IU&#47;kg was achieved &#40;95&#37; CI&#58; &#8211;0&#46;12&#59; &#8211;0&#46;25&#59; <span class="elsevierStyleItalic">p</span>&#160;&#60;&#160;0&#46;0001&#41; and at 12 months&#44; this reduction was maintained and increased&#44; reaching &#8211;0&#46;23 IU&#47;kg &#40;95&#37; CI&#58; &#8211;0&#46;16&#59; &#8211;0&#46;30&#59; <span class="elsevierStyleItalic">p</span>&#160;&#60;&#160;0&#46;0001&#41;&#46;</p><p id="par0215" class="elsevierStylePara elsevierViewall">In the GLP-1ra experienced subgroup&#44; the initial mean dose was 0&#46;64 IU&#47;kg of weight &#40;n&#160;&#61;&#160;17&#41;&#46; At six months&#44; a reduction of just &#8211;0&#46;01 IU&#47;kg was achieved &#40;95&#37; CI&#58; &#8211;0&#46;06&#59; 0&#46;08&#59; <span class="elsevierStyleItalic">p</span>&#160;&#62;&#160;0&#46;9999&#41; and at 12 months&#44; a reduction of 0&#46;03 IU was achieved &#40;95&#37; CI&#58; &#8211;0&#46;06&#59; 0&#46;08&#59; <span class="elsevierStyleItalic">p</span>&#160;&#61;&#160;0&#46;4051&#41; &#40;<a class="elsevierStyleCrossRef" href="#tbl0010">Table 2</a>&#41;&#46;</p><elsevierMultimedia ident="tbl0010"></elsevierMultimedia><p id="par0220" class="elsevierStylePara elsevierViewall">No patients reported grade 3 or severe hypoglycemic events during the course of this study&#46; The number of mild or moderate hypoglycemic events was not quantified given that they were not considered clinically relevant&#46;</p></span></span><span id="sec0065" class="elsevierStyleSection elsevierViewall"><span class="elsevierStyleSectionTitle" id="sect0125">Discussion</span><p id="par0225" class="elsevierStylePara elsevierViewall">This work has shown that weekly subcutaneous semaglutide in patients treated with insulin produces a significant reduction in HbA1c&#44; weight&#44; and insulin needs&#46; This reduction was greater in patients who had not previously been treated with another GLP-1ra&#46; The drug was well tolerated and just six &#40;5&#37;&#41; patients needed to withdraw from the study due to adverse effects&#46;</p><p id="par0230" class="elsevierStylePara elsevierViewall">Compared to the Canadian SURE study<a class="elsevierStyleCrossRef" href="#bib0095"><span class="elsevierStyleSup">19</span></a>&#44; published with real-world data on semaglutide added to insulin&#44; the reduction in HbA1c was very similar &#40;&#8211;0&#46;86&#37; vs&#46; &#8211;0&#46;90&#37;&#41;&#44; as was the reduction in body weight &#40;&#8211;5&#46;33&#160;kg vs&#46; &#8211;4&#46;5&#160;kg&#41;&#46; In addition&#44; patients started from an initial weight that was also similar &#40;99&#46;2&#160;kg SURE vs&#46; 97&#46;29&#160;kg in our study&#41;&#46; It is important to note that all patients in this study were in treatment with insulin &#40;during and prior to the study&#41;&#44; but only 41&#37; of patients were treated with insulin in the SURE study &#40;other subgroups were only treated with oral hypoglycemic agents&#41;&#46;</p><p id="par0235" class="elsevierStylePara elsevierViewall">If we compare our data to those obtained in other non-real-world studies<a class="elsevierStyleCrossRefs" href="#bib0085"><span class="elsevierStyleSup">17&#44;18</span></a>&#44; the conclusion is the same&#58; combined insulin and semaglutide treatment significantly improved glycemic control in terms of a reduction in HbA1c and the number of patients within the target &#40;HbA1c &#60;7&#37;&#41;&#44; with associated weight loss&#46;</p><p id="par0240" class="elsevierStylePara elsevierViewall">Overall&#44; our results support the role of semaglutide combined with insulin as a valuable intensification strategy for producing a clinical benefit in the management of DM2&#46; Along these lines&#44; the updated consensus document from the American Diabetes Association and the European Association for the Study of Diabetes &#40;EASD&#41; suggests intensifying treatment with GLP-1ra&#44; among other drugs including SGLT-2is or prandial insulin&#44; in patients who cannot meet glycemic targets at the start of insulin treatment in combination with oral medication<a class="elsevierStyleCrossRef" href="#bib0005"><span class="elsevierStyleSup">1</span></a>&#46;</p><p id="par0245" class="elsevierStylePara elsevierViewall">Due to the disease&#8217;s natural history&#44; many patients with DM2 need insulin to reach their glycemic control target&#46; A common approach for starting insulin therapy is a single injection of basal insulin&#44; which is eventually titrated to optimize treatment<a class="elsevierStyleCrossRef" href="#bib0005"><span class="elsevierStyleSup">1</span></a>&#46; If necessary&#44; treatment intensification to reach the glycemic target can include the addition of one or more rapid-acting insulin doses before meals &#40;basal-plus or basal-bolus regimen&#41; or a change to a premixed insulin regimen in which there is a fixed amount of intermediate-acting or short- or rapid-acting insulin&#46;</p><p id="par0250" class="elsevierStylePara elsevierViewall">Although these regimens lead to a similar decrease in HbA1c levels<a class="elsevierStyleCrossRef" href="#bib0100"><span class="elsevierStyleSup">20</span></a>&#44; there is a certain degree of reluctance to intensifying insulin therapy due to possible adverse effects &#40;i&#46;e&#46;&#44; an increase in the number of hypoglycemic events and weight gain&#41; and practical issues &#40;i&#46;e&#46;&#44; difficulties in educating patients on injection therapy&#41;&#46; In this context&#44; the addition of semaglutide to insulin can be a valid therapeutic option for improving glycemic control and minimizing adverse events associated with insulin intensification&#46;</p><p id="par0255" class="elsevierStylePara elsevierViewall">The subgroup analysis shows that the patients who benefited most from treatment with semaglutide are those not previously treated with another GLP-1ra&#44; i&#46;e&#46;&#44; those who had not been treated with another drug from the same family&#46; Those who had previously been treated with another GLP-1ra had favorable results&#44; especially in terms of weight loss&#44; but not to the same extent in terms of glycemic control&#46;</p><p id="par0260" class="elsevierStylePara elsevierViewall">In conclusion&#44; combined insulin and semaglutide therapy is a valuable treatment strategy for improving metabolic control in the management of DM2<a class="elsevierStyleCrossRef" href="#bib0105"><span class="elsevierStyleSup">21</span></a>&#46;</p></span><span id="sec0070" class="elsevierStyleSection elsevierViewall"><span class="elsevierStyleSectionTitle" id="sect0130">Funding</span><p id="par0265" class="elsevierStylePara elsevierViewall">The authors declare that they have not received funding for conducting this study&#46;</p></span><span id="sec0075" class="elsevierStyleSection elsevierViewall"><span class="elsevierStyleSectionTitle" id="sect0135">Conflicts of interest</span><p id="par0270" class="elsevierStylePara elsevierViewall">The authors declare no conflicts of interest&#46;</p></span></span>"
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              "titulo" => "HbA1c"
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              "titulo" => "Weight"
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              "titulo" => "Units of insulin&#47;kg of weight"
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    "fechaRecibido" => "2022-02-06"
    "fechaAceptado" => "2022-03-04"
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            0 => "Type 2 diabetes"
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            2 => "Insulin resistance"
            3 => "Glucose control"
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            0 => "Diabetes tipo 2"
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        "titulo" => "Abstract"
        "resumen" => "<span id="abst0005" class="elsevierStyleSection elsevierViewall"><span class="elsevierStyleSectionTitle" id="sect0010">Objectives</span><p id="spar0040" class="elsevierStyleSimplePara elsevierViewall">This work aims to determine the real-life anthropometric and analytical benefits of adding subcutaneous semaglutide to previous insulin treatment in patients with type 2 diabetes&#46;</p></span> <span id="abst0010" class="elsevierStyleSection elsevierViewall"><span class="elsevierStyleSectionTitle" id="sect0015">Methods</span><p id="spar0045" class="elsevierStyleSimplePara elsevierViewall">This is a descriptive&#44; retrospective&#44; open-label study describing the clinical and anthropometric characteristics of 117 patients diagnosed with type 2 diabetes followed-up on in the Endocrinology and Nutrition outpatient clinic of the Hospital Universitario Central de Asturias for 53 weeks after starting treatment with subcutaneous semaglutide &#40;October&#8211;December 2019&#41;&#46; All patients were on previous insulin treatment with or without oral antidiabetics&#46;</p></span> <span id="abst0015" class="elsevierStyleSection elsevierViewall"><span class="elsevierStyleSectionTitle" id="sect0020">Results</span><p id="spar0050" class="elsevierStyleSimplePara elsevierViewall">Of the 117 initial patients&#44; 17 did not complete the study due to adverse effects &#40;nausea&#44; vomiting&#41;&#44; the physician&#8217;s decision&#44; or loss to follow-up&#46; Twelve months &#40;week 53&#41; after starting semaglutide&#44; there was a decrease in HbA1c of 0&#46;74&#37; &#40;95&#37; CI 0&#46;59&#8211;1&#46;14&#44; <span class="elsevierStyleItalic">p</span>&#160;&#60;&#160;0&#46;05&#41; as well as 3&#46;61 kg of weight loss &#40;95&#37; CI 2&#46;30&#8211;4&#46;92&#44; <span class="elsevierStyleItalic">p</span>&#160;&#60;&#160;0&#46;05&#41; and a decline in total insulin of 15&#46;88 IU &#40;95&#37; CI 10&#46;98&#8211;20&#46;74&#44; <span class="elsevierStyleItalic">p</span>&#160;&#60;&#160;0&#46;05&#41; from baseline figures&#46; In patients without prior GLP-1 receptor analogs &#40;GLP-1ra&#41;&#44; the effect in terms of a reduction in HbA1c&#44; weight&#44; and the total insulin dose was statistically significant&#46; However&#44; in patients pre-treated with GLP-1ra only had improvements in terms of weight loss&#46; No serious adverse events were observed&#46;</p></span> <span id="abst0020" class="elsevierStyleSection elsevierViewall"><span class="elsevierStyleSectionTitle" id="sect0025">Conclusions</span><p id="spar0060" class="elsevierStyleSimplePara elsevierViewall">The addition of subcutaneous semaglutide to prior insulin treatment with or without oral antidiabetics safely led to a decrease in HbA1c&#44; weight&#44; and the insulin dose&#46; This effect is greater in GLP-1ra naive patients&#46;</p></span>"
        "secciones" => array:4 [
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        "resumen" => "<span id="abst0025" class="elsevierStyleSection elsevierViewall"><span class="elsevierStyleSectionTitle" id="sect0035">Objetivos</span><p id="spar0065" class="elsevierStyleSimplePara elsevierViewall">Determinar en la vida real los beneficios antropom&#233;tricos y anal&#237;ticos de la adici&#243;n de semaglutida por v&#237;a subcut&#225;nea al tratamiento previo con insulina en pacientes con diabetes tipo 2&#46;</p></span> <span id="abst0030" class="elsevierStyleSection elsevierViewall"><span class="elsevierStyleSectionTitle" id="sect0040">M&#233;todos</span><p id="spar0070" class="elsevierStyleSimplePara elsevierViewall">Estudio descriptivo&#44; retrospectivo y abierto en el que se describen caracter&#237;sticas cl&#237;nicas y antropom&#233;tricas de 117 pacientes diagnosticados de diabetes tipo 2 seguidos en las consultas externas de Endocrinolog&#237;a y Nutrici&#243;n del Hospital Universitario Central de Asturias a lo largo de 53 semanas tras el inicio de tratamiento con semaglutida subcut&#225;nea &#40;octubre&#8211;diciembre 2019&#41;&#46; Todos los pacientes estaban en tratamiento previo con insulina&#44; con o sin antidiab&#233;ticos orales&#46;</p></span> <span id="abst0035" class="elsevierStyleSection elsevierViewall"><span class="elsevierStyleSectionTitle" id="sect0045">Resultados</span><p id="spar0075" class="elsevierStyleSimplePara elsevierViewall">De los 117 pacientes iniciales&#44; 17 no completaron el estudio debido a efectos adversos &#40;n&#225;useas&#44; v&#243;mitos&#41;&#44; decisi&#243;n cl&#237;nica y p&#233;rdida de seguimiento&#46; A los 12 meses &#40;semana 53&#41; del inicio de la semaglutida se obtuvo un descenso de HbA1c de 0&#44;74&#37; &#40;IC 95&#37; 0&#44;59&#8211;1&#44;14&#44; p&#160;&#60;&#160;0&#44;05&#41;&#44; as&#237; como de 3&#44;61 kg de peso &#40;IC 95&#37; 2&#44;30&#8211;4&#44;92&#44; p&#160;&#60;&#160;0&#44;05&#41;&#44; y de 15&#44;88 UI de insulina total &#40;IC 95&#37; 10&#44;98&#8211;20&#44;74&#44; p&#160;&#60;&#160;0&#44;05&#41; respecto a las cifras basales&#46; En pacientes sin an&#225;logo del receptor de GLP-1 &#40;arGLP-1&#41; previo&#44; el efecto en la disminuci&#243;n de HbA1c&#44; el peso y la dosis total de insulina fue estad&#237;sticamente significativo&#59; sin embargo&#44; los pacientes pretratados con arGLP-1 solo tuvieron mejor&#237;a en la reducci&#243;n de peso&#46; No se observaron eventos adversos graves&#46;</p></span> <span id="abst0040" class="elsevierStyleSection elsevierViewall"><span class="elsevierStyleSectionTitle" id="sect0050">Conclusiones</span><p id="spar0085" class="elsevierStyleSimplePara elsevierViewall">La adici&#243;n de semaglutida subcut&#225;nea al tratamiento previo con insulina con o sin antidiab&#233;ticos orales induce una disminuci&#243;n de HbA1c&#44; peso y dosis de insulina de forma segura&#46; Este efecto es mayor en pacientes na&#239;ve para tratamiento con arGLP-1&#46;</p></span>"
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        "nota" => "<p class="elsevierStyleNotepara" id="npar0005">Please cite this article as&#58; Ares-Blanco J&#44; Pujante-Alarc&#243;n P&#44; Lambert C&#44; Morales-S&#225;nchez P&#44; Delgado-&#193;lvarez E&#44; Men&#233;ndez-Torre EL&#46; Efectos en vida real de la adici&#243;n de semaglutida subcut&#225;nea semanal al tratamiento con insulina en diabetes mellitus tipo 2&#46; Rev Clin Esp&#46; 2022&#59;222&#58;516&#8211;522&#46;</p>"
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                  \t\t\t\t" scope="col" style="border-bottom: 2px solid black">&nbsp;\t\t\t\t\t\t\n
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                  \t\t\t\t">117&nbsp;\t\t\t\t\t\t\n
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                  \t\t\t\t">80 &#40;69&#41;&nbsp;\t\t\t\t\t\t\n
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                  \t\t\t\t\ttop\n
                  \t\t\t\t">37 &#40;32&#41;&nbsp;\t\t\t\t\t\t\n
                  \t\t\t\t</td></tr><tr title="table-row"><td class="td-with-role" title="\n
                  \t\t\t\t\ttable-entry\n
                  \t\t\t\t ; entry_with_role_rowhead " align="left" valign="\n
                  \t\t\t\t\ttop\n
                  \t\t\t\t">Time since onset &#40;years&#41;&nbsp;\t\t\t\t\t\t\n
                  \t\t\t\t</td><td class="td" title="\n
                  \t\t\t\t\ttable-entry\n
                  \t\t\t\t  " align="left" valign="\n
                  \t\t\t\t\ttop\n
                  \t\t\t\t">16&#46;64&#160;&#177;&#160;7&#46;99&nbsp;\t\t\t\t\t\t\n
                  \t\t\t\t</td><td class="td" title="\n
                  \t\t\t\t\ttable-entry\n
                  \t\t\t\t  " align="left" valign="\n
                  \t\t\t\t\ttop\n
                  \t\t\t\t">16&#46;08&#160;&#177;&#160;8&#46;52&nbsp;\t\t\t\t\t\t\n
                  \t\t\t\t</td><td class="td" title="\n
                  \t\t\t\t\ttable-entry\n
                  \t\t\t\t  " align="left" valign="\n
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                  \t\t\t\t">17&#46;86&#160;&#177;&#160;6&#46;65&nbsp;\t\t\t\t\t\t\n
                  \t\t\t\t</td></tr><tr title="table-row"><td class="td-with-role" title="\n
                  \t\t\t\t\ttable-entry\n
                  \t\t\t\t ; entry_with_role_rowhead " align="left" valign="\n
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                  \t\t\t\t">Age &#40;years&#41;&nbsp;\t\t\t\t\t\t\n
                  \t\t\t\t</td><td class="td" title="\n
                  \t\t\t\t\ttable-entry\n
                  \t\t\t\t  " align="left" valign="\n
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                  \t\t\t\t">64&#46;23&#160;&#177;&#160;9&#46;43&nbsp;\t\t\t\t\t\t\n
                  \t\t\t\t</td><td class="td" title="\n
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                  \t\t\t\t  " align="left" valign="\n
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                  \t\t\t\t">63&#46;51&#160;&#177;&#160;9&#46;47&nbsp;\t\t\t\t\t\t\n
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                  \t\t\t\t\ttable-entry\n
                  \t\t\t\t  " align="left" valign="\n
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                  \t\t\t\t">65&#46;78&#160;&#177;&#160;9&#46;30&nbsp;\t\t\t\t\t\t\n
                  \t\t\t\t</td></tr><tr title="table-row"><td class="td-with-role" title="\n
                  \t\t\t\t\ttable-entry\n
                  \t\t\t\t ; entry_with_role_rowhead " align="left" valign="\n
                  \t\t\t\t\ttop\n
                  \t\t\t\t">No&#46; of OAD&nbsp;\t\t\t\t\t\t\n
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                  \t\t\t\t\ttable-entry\n
                  \t\t\t\t  " align="left" valign="\n
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                  \t\t\t\t">1&#46;62&#160;&#177;&#160;1&#46;02&nbsp;\t\t\t\t\t\t\n
                  \t\t\t\t</td><td class="td" title="\n
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                  \t\t\t\t  " align="left" valign="\n
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                  \t\t\t\t">1&#46;63&#160;&#177;&#160;1&#46;09&nbsp;\t\t\t\t\t\t\n
                  \t\t\t\t</td><td class="td" title="\n
                  \t\t\t\t\ttable-entry\n
                  \t\t\t\t  " align="left" valign="\n
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                  \t\t\t\t">1&#46;62&#160;&#177;&#160;0&#46;86&nbsp;\t\t\t\t\t\t\n
                  \t\t\t\t</td></tr><tr title="table-row"><td class="td-with-role" title="\n
                  \t\t\t\t\ttable-entry\n
                  \t\t\t\t ; entry_with_role_rowhead " align="left" valign="\n
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                  \t\t\t\t">SGLT2i &#40;&#37;&#41;&nbsp;\t\t\t\t\t\t\n
                  \t\t\t\t</td><td class="td" title="\n
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                  \t\t\t\t  " align="left" valign="\n
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                  \t\t\t\t">54 &#40;46&#41;&nbsp;\t\t\t\t\t\t\n
                  \t\t\t\t</td><td class="td" title="\n
                  \t\t\t\t\ttable-entry\n
                  \t\t\t\t  " align="left" valign="\n
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                  \t\t\t\t">33 &#40;41&#41;&nbsp;\t\t\t\t\t\t\n
                  \t\t\t\t</td><td class="td" title="\n
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                  \t\t\t\t  " align="left" valign="\n
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                  \t\t\t\t">21 &#40;57&#41;&nbsp;\t\t\t\t\t\t\n
                  \t\t\t\t</td></tr><tr title="table-row"><td class="td-with-role" title="\n
                  \t\t\t\t\ttable-entry\n
                  \t\t\t\t ; entry_with_role_rowhead " align="left" valign="\n
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                  \t\t\t\t">Weight &#40;kg&#41;&nbsp;\t\t\t\t\t\t\n
                  \t\t\t\t</td><td class="td" title="\n
                  \t\t\t\t\ttable-entry\n
                  \t\t\t\t  " align="left" valign="\n
                  \t\t\t\t\ttop\n
                  \t\t\t\t">97&#46;28&#160;&#177;&#160;18&#46;43&nbsp;\t\t\t\t\t\t\n
                  \t\t\t\t</td><td class="td" title="\n
                  \t\t\t\t\ttable-entry\n
                  \t\t\t\t  " align="left" valign="\n
                  \t\t\t\t\ttop\n
                  \t\t\t\t">95&#46;54&#160;&#177;&#160;19&#46;21&nbsp;\t\t\t\t\t\t\n
                  \t\t\t\t</td><td class="td" title="\n
                  \t\t\t\t\ttable-entry\n
                  \t\t\t\t  " align="left" valign="\n
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                  \t\t\t\t">100&#46;95&#160;&#177;&#160;16&#46;34&nbsp;\t\t\t\t\t\t\n
                  \t\t\t\t</td></tr><tr title="table-row"><td class="td-with-role" title="\n
                  \t\t\t\t\ttable-entry\n
                  \t\t\t\t ; entry_with_role_rowhead " align="left" valign="\n
                  \t\t\t\t\ttop\n
                  \t\t\t\t">HbA1c &#40;&#37;&#41;&nbsp;\t\t\t\t\t\t\n
                  \t\t\t\t</td><td class="td" title="\n
                  \t\t\t\t\ttable-entry\n
                  \t\t\t\t  " align="left" valign="\n
                  \t\t\t\t\ttop\n
                  \t\t\t\t">8&#46;31&#160;&#177;&#160;1&#46;33&nbsp;\t\t\t\t\t\t\n
                  \t\t\t\t</td><td class="td" title="\n
                  \t\t\t\t\ttable-entry\n
                  \t\t\t\t  " align="left" valign="\n
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                  \t\t\t\t">8&#46;39&#160;&#177;&#160;1&#46;33&nbsp;\t\t\t\t\t\t\n
                  \t\t\t\t</td><td class="td" title="\n
                  \t\t\t\t\ttable-entry\n
                  \t\t\t\t  " align="left" valign="\n
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                  \t\t\t\t">8&#46;13&#160;&#177;&#160;1&#46;32&nbsp;\t\t\t\t\t\t\n
                  \t\t\t\t</td></tr><tr title="table-row"><td class="td-with-role" title="\n
                  \t\t\t\t\ttable-entry\n
                  \t\t\t\t ; entry_with_role_rowhead " align="left" valign="\n
                  \t\t\t\t\ttop\n
                  \t\t\t\t">HbA1c &#60;7&#37;&nbsp;\t\t\t\t\t\t\n
                  \t\t\t\t</td><td class="td" title="\n
                  \t\t\t\t\ttable-entry\n
                  \t\t\t\t  " align="left" valign="\n
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                  \t\t\t\t">17 &#40;15&#41;&nbsp;\t\t\t\t\t\t\n
                  \t\t\t\t</td><td class="td" title="\n
                  \t\t\t\t\ttable-entry\n
                  \t\t\t\t  " align="left" valign="\n
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                  \t\t\t\t">8 &#40;10&#41;&nbsp;\t\t\t\t\t\t\n
                  \t\t\t\t</td><td class="td" title="\n
                  \t\t\t\t\ttable-entry\n
                  \t\t\t\t  " align="left" valign="\n
                  \t\t\t\t\ttop\n
                  \t\t\t\t">9 &#40;24&#41;&nbsp;\t\t\t\t\t\t\n
                  \t\t\t\t</td></tr><tr title="table-row"><td class="td-with-role" title="\n
                  \t\t\t\t\ttable-entry\n
                  \t\t\t\t ; entry_with_role_rowhead " align="left" valign="\n
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                  \t\t\t\t</td><td class="td" title="\n
                  \t\t\t\t\ttable-entry\n
                  \t\t\t\t  " align="left" valign="\n
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                  \t\t\t\t">63&#46;78&#160;&#177;&#160;39&#46;69&nbsp;\t\t\t\t\t\t\n
                  \t\t\t\t</td><td class="td" title="\n
                  \t\t\t\t\ttable-entry\n
                  \t\t\t\t  " align="left" valign="\n
                  \t\t\t\t\ttop\n
                  \t\t\t\t">63&#46;00&#160;&#177;&#160;38&#46;64&nbsp;\t\t\t\t\t\t\n
                  \t\t\t\t</td><td class="td" title="\n
                  \t\t\t\t\ttable-entry\n
                  \t\t\t\t  " align="left" valign="\n
                  \t\t\t\t\ttop\n
                  \t\t\t\t">65&#46;46&#160;&#177;&#160;42&#46;36&nbsp;\t\t\t\t\t\t\n
                  \t\t\t\t</td></tr><tr title="table-row"><td class="td-with-role" title="\n
                  \t\t\t\t\ttable-entry\n
                  \t\t\t\t ; entry_with_role_rowhead " align="left" valign="\n
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                  \t\t\t\t">Basal dose &#40;IU&#41;&nbsp;\t\t\t\t\t\t\n
                  \t\t\t\t</td><td class="td" title="\n
                  \t\t\t\t\ttable-entry\n
                  \t\t\t\t  " align="left" valign="\n
                  \t\t\t\t\ttop\n
                  \t\t\t\t">44&#46;29&#160;&#177;&#160;21&#46;33&nbsp;\t\t\t\t\t\t\n
                  \t\t\t\t</td><td class="td" title="\n
                  \t\t\t\t\ttable-entry\n
                  \t\t\t\t  " align="left" valign="\n
                  \t\t\t\t\ttop\n
                  \t\t\t\t">42&#46;85&#160;&#177;&#160;20&#46;23&nbsp;\t\t\t\t\t\t\n
                  \t\t\t\t</td><td class="td" title="\n
                  \t\t\t\t\ttable-entry\n
                  \t\t\t\t  " align="left" valign="\n
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                  \t\t\t\t">47&#46;44&#160;&#177;&#160;23&#46;52&nbsp;\t\t\t\t\t\t\n
                  \t\t\t\t</td></tr><tr title="table-row"><td class="td-with-role" title="\n
                  \t\t\t\t\ttable-entry\n
                  \t\t\t\t ; entry_with_role_rowhead " align="left" valign="\n
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                  \t\t\t\t">Prandial dose &#40;IU&#41;&nbsp;\t\t\t\t\t\t\n
                  \t\t\t\t</td><td class="td" title="\n
                  \t\t\t\t\ttable-entry\n
                  \t\t\t\t  " align="left" valign="\n
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                  \t\t\t\t">25&#46;69&#160;&#177;&#160;19&#46;49&nbsp;\t\t\t\t\t\t\n
                  \t\t\t\t</td><td class="td" title="\n
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                  \t\t\t\t  " align="left" valign="\n
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                  \t\t\t\t">20&#46;15&#160;&#177;&#160;25&#46;27&nbsp;\t\t\t\t\t\t\n
                  \t\t\t\t</td><td class="td" title="\n
                  \t\t\t\t\ttable-entry\n
                  \t\t\t\t  " align="left" valign="\n
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                  \t\t\t\t">18&#46;05&#160;&#177;&#160;25&#46;55&nbsp;\t\t\t\t\t\t\n
                  \t\t\t\t</td></tr><tr title="table-row"><td class="td-with-role" title="\n
                  \t\t\t\t\ttable-entry\n
                  \t\t\t\t ; entry_with_role_rowhead " align="left" valign="\n
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                  \t\t\t\t">IU insulin&#47;kg weight&nbsp;\t\t\t\t\t\t\n
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                  \t\t\t\t  " align="left" valign="\n
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                  \t\t\t\t">0&#46;67&#160;&#177;&#160;0&#46;44&nbsp;\t\t\t\t\t\t\n
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                  \t\t\t\t  " align="left" valign="\n
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                  \t\t\t\t">0&#46;69&#160;&#177;&#160;0&#46;46&nbsp;\t\t\t\t\t\t\n
                  \t\t\t\t</td><td class="td" title="\n
                  \t\t\t\t\ttable-entry\n
                  \t\t\t\t  " align="left" valign="\n
                  \t\t\t\t\ttop\n
                  \t\t\t\t">0&#46;64&#160;&#177;&#160;0&#46;39&nbsp;\t\t\t\t\t\t\n
                  \t\t\t\t</td></tr></tbody></table>
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                  "referenciaCompleta" => "Standards of Medical Care in Diabetes-2022 Abridged for Primary Care Providers&#46; Clin Diabetes &#91;Internet&#93;&#46; 2021 Dec 17 &#91;accessed 30 Dec 2021&#93;&#59; Available from&#58; <a target="_blank" href="https://diabetesjournals.org/clinical/article/doi/10.2337/cd22-as01/139035/Standards-of-Medical-Care-in-Diabetes-2022">https&#58;&#47;&#47;diabetesjournals&#46;org&#47;clinical&#47;article&#47;doi&#47;10&#46;2337&#47;cd22-as01&#47;139035&#47;Standards-of-Medical-Care-in-Diabetes-2022</a>&#46;"
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                0 => array:2 [
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                    0 => array:2 [
                      "titulo" => "The treat-to-target trial&#58; randomized addition of glargine or human NPH insulin to oral therapy of type 2 diabetic patients"
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                        0 => array:2 [
                          "etal" => false
                          "autores" => array:3 [
                            0 => "M&#46;C&#46; Riddle"
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                            2 => "J&#46; Gerich"
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                  "host" => array:2 [
                    0 => array:1 [
                      "Revista" => array:5 [
                        "tituloSerie" => "Diabetes Care &#91;Internet&#93;&#46;"
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                        "paginaInicial" => "3080"
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                        "link" => "https&#58;&#47;&#47;pubmed&#46;ncbi&#46;nlm&#46;nih&#46;gov&#47;14578243"
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                0 => array:2 [
                  "contribucion" => array:1 [
                    0 => array:2 [
                      "titulo" => "A randomised&#44; 52-week&#44; treat-to-target trial comparing insulin detemir with insulin glargine when administered as add-on to glucose-lowering drugs in insulin-naive people with type 2 diabetes"
                      "autores" => array:1 [
                        0 => array:2 [
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                            0 => "J&#46; Rosenstock"
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                            2 => "P&#46;D&#46; Home"
                            3 => "J&#46; Larsen"
                            4 => "C&#46; Koenen"
                            5 => "G&#46; Schernthaner"
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                        "tituloSerie" => "Diabetologia &#91;Internet&#93;&#46;"
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                            "url" => "https://www.ncbi.nlm.nih.gov/pubmed/18204830"
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                    0 => array:2 [
                      "titulo" => "Insulin initiation in primary care for patients with type 2 diabetes&#58; 3-year follow-up study"
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                        0 => array:2 [
                          "etal" => false
                          "autores" => array:3 [
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                      "doi" => "10.1016/j.pcd.2010.03.001"
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Original article
Real-life effects of adding weekly subcutaneous semaglutide to insulin for the treatment of type 2 diabetes mellitus
Efectos en vida real de la adición de semaglutida subcutánea semanal al tratamiento con insulina en diabetes mellitus tipo 2
J. Ares-Blancoa,b,c,
Corresponding author
jessiaresb@gmail.com

Corresponding author.
, P. Pujante-Alarcóna,b, C. Lambertb,d, P. Morales-Sánchezb,e, E. Delgado-Álvareza,b,c,e, E.L. Menéndez-Torrea,b,c,e
a Servicio de Endocrinología y Nutrición, Hospital Universitario Central de Asturias, Oviedo, Asturias, Spain
b Instituto de Investigación Sanitaria del Principado de Asturias (ISPA), Grupo ENDO, Oviedo, Asturias, Spain
c Departamento de Medicina, Universidad de Oviedo, Oviedo, Asturias, Spain
d Universidad de Barcelona, Barcelona, Spain
e Centro de Investigación Biomédica en Red de Enfermedades Raras (CIBERER), Spain
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          "en" => "<p id="spar0010" class="elsevierStyleSimplePara elsevierViewall">Data on the evolution of weight &#40;kg&#41; in six and 12 months in the three groups&#58; total group&#44; GLP-1ra naive group&#44; and GLP-1ra experienced group&#46; GLP-1ra&#58; GLP-1 receptor agonist&#46;</p>"
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    "textoCompleto" => "<span class="elsevierStyleSections"><span id="sec0005" class="elsevierStyleSection elsevierViewall"><span class="elsevierStyleSectionTitle" id="sect0065">Introduction</span><p id="par0005" class="elsevierStylePara elsevierViewall">Type 2 diabetes mellitus &#40;DM2&#41; is a slowly progressive disease&#46; On occasion&#44; due to the gradual decline in pancreatic beta cell function&#44; it is necessary to intensify the initial treatment to maintain adequate glycemic control&#46;</p><p id="par0010" class="elsevierStylePara elsevierViewall">Treatment with insulin &#40;initially mostly basal&#41; is frequently used following the failure of several oral lipid-lowering drugs maintain HbA1c at target levels<a class="elsevierStyleCrossRef" href="#bib0005"><span class="elsevierStyleSup">1</span></a>&#46; However&#44; data published in various randomized clinical trials &#40;RCTs&#41;<a class="elsevierStyleCrossRefs" href="#bib0010"><span class="elsevierStyleSup">2&#44;3</span></a> and cohort studies<a class="elsevierStyleCrossRefs" href="#bib0020"><span class="elsevierStyleSup">4&#44;5</span></a> show that a significant proportion of patients who receive insulin therapy do not reach glycemic control targets either&#46;</p><p id="par0015" class="elsevierStylePara elsevierViewall">When basal insulin requirements exceed 0&#46;5&#160;IU&#47;kg of weight&#44; subsequent dose increases do not result in an improvement in glycemic control&#44; but do result in an increase in weight and hypoglycemic episodes<a class="elsevierStyleCrossRef" href="#bib0030"><span class="elsevierStyleSup">6</span></a>&#46; At present&#44; when faced with this situation&#44; the American Diabetes Association recommends associating treatment with a GLP-1 receptor agonist &#40;GLP-1ra&#41; in patients in which atherosclerotic cardiovascular disease and&#47;or obesity are predominant<a class="elsevierStyleCrossRef" href="#bib0005"><span class="elsevierStyleSup">1</span></a>&#46;</p><p id="par0020" class="elsevierStylePara elsevierViewall">The benefit of combined insulin and GLP-1ra treatment lies in the sum of their components&#8217; synergic and complementary effects<a class="elsevierStyleCrossRefs" href="#bib0035"><span class="elsevierStyleSup">7&#44;8</span></a>&#46;</p><p id="par0025" class="elsevierStylePara elsevierViewall">GLP-1ras improve insulin secretion in a glucose-dependent manner&#44; suppress glucagon secretion&#44; act on post-prandial blood glucose by slowing stomach emptying&#44; and promote weight loss&#46; All of this improves glycemic control with a low risk of hypoglycemia and weight gain<a class="elsevierStyleCrossRefs" href="#bib0035"><span class="elsevierStyleSup">7&#44;8</span></a>&#46;</p><p id="par0030" class="elsevierStylePara elsevierViewall">Semaglutide &#40;Novo Nordisk A&#47;S&#44; Denmark&#41; is a GLP-1ra&#46; To improve glycemic control in adults with DM2&#44; in addition to diet and exercise&#44; semaglutide can be administered in both subcutaneous &#40;SC&#41; formulations once per week<a class="elsevierStyleCrossRef" href="#bib0045"><span class="elsevierStyleSup">9</span></a> or oral formulations once per day<a class="elsevierStyleCrossRef" href="#bib0050"><span class="elsevierStyleSup">10</span></a>&#46;</p><p id="par0035" class="elsevierStylePara elsevierViewall">In the SUSTAIN clinical trials&#44; semaglutide SC was demonstrated to be superior by reducing HbA1c and body weight compared to the placebo and a wide variety of active comparators&#44; including SGLT-2is&#44; other GLP-1ras&#44; and insulin glargine&#44; with a safety profile similar to that of other GLP-1ras<a class="elsevierStyleCrossRefs" href="#bib0055"><span class="elsevierStyleSup">11&#8211;16</span></a>&#46;</p><p id="par0040" class="elsevierStylePara elsevierViewall">However&#44; the population represented in RCTs is not the same as patients in clinical practice&#44; given that the former must meet strict inclusion and exclusion criteria&#46; Real-world studies aim to verify the findings of these RCTs and are important for knowing the efficacy and safety of the drug in clinical practice settings&#46;</p><p id="par0045" class="elsevierStylePara elsevierViewall">Various studies have compared the combination of a GLP-1ra and insulin to an intensification of the insulin regimen<a class="elsevierStyleCrossRefs" href="#bib0085"><span class="elsevierStyleSup">17&#44;18</span></a>&#46; Meta-analyses indicate that glycemic control is similar or better with the addition of GLP-1ras with benefits over insulin intensification&#44; including a reduction in body weight and lower incidence of hypoglycemic episodes&#46;</p></span><span id="sec0010" class="elsevierStyleSection elsevierViewall"><span class="elsevierStyleSectionTitle" id="sect0070">Objectives</span><p id="par0050" class="elsevierStylePara elsevierViewall">The purpose of this study is to determine the benefits in clinical practice of starting semaglutide SC in patients who have previously been treated with subcutaneous insulin&#46;</p><p id="par0055" class="elsevierStylePara elsevierViewall">The primary objective was the change in HbA1c values at six and 12 months from the baseline value &#40;&#37;-point&#41;&#46; Secondary aims included the change in body weight &#40;kg&#41;&#44; total insulin dose &#40;IU&#41;&#44; and insulin dose per weight &#40;IU&#47;kg&#41; from baseline to the two time points&#46;</p><p id="par0060" class="elsevierStylePara elsevierViewall">In addition&#44; the study seeks to confirm the drug&#8217;s safety in this subgroup of the population with diabetes by determining the rate of treatment suspensions and patient dropouts as well as severe hypoglycemic episodes&#46;</p></span><span id="sec0015" class="elsevierStyleSection elsevierViewall"><span class="elsevierStyleSectionTitle" id="sect0075">Materials and methods</span><span id="sec0020" class="elsevierStyleSection elsevierViewall"><span class="elsevierStyleSectionTitle" id="sect0080">Study design and location</span><p id="par0065" class="elsevierStylePara elsevierViewall">This retrospective&#44; open-label&#44; 53-week&#44; observational study evaluated the real-world clinical repercussions of the addition of weekly semaglutide SC in adults with DM2 previously treated with insulin followed-up on in the Endocrinology and Nutrition Department outpatient clinic of the Central University Hospital of Asturias&#46;</p></span><span id="sec0025" class="elsevierStyleSection elsevierViewall"><span class="elsevierStyleSectionTitle" id="sect0085">Study population</span><p id="par0070" class="elsevierStylePara elsevierViewall"><span class="elsevierStyleItalic">Inclusion criteria&#58;</span> patients &#8805;18 years with DM2 with more 12 weeks since onset who were already in treatment with insulin &#40;basal&#44; basal-bolus&#44; or premixed&#41;&#46;</p><p id="par0075" class="elsevierStylePara elsevierViewall"><span class="elsevierStyleItalic">Exclusion criteria&#58;</span> treatment with any investigational drug &#40;a drug not currently approved for treatment&#41; within 90 days prior to inclusion&#44; hypersensitivity to semaglutide or any of its excipients&#44; and an estimated glomerular filtration rate &#60;15&#160;mL&#47;min&#47;1&#46;73&#160;m<span class="elsevierStyleSup">2</span> on the most recent blood test available&#46;</p><p id="par0080" class="elsevierStylePara elsevierViewall">The decision to start treatment with semaglutide SC&#44; prescribe other hypoglycemic treatments&#44; or prescribe a diet and exercise regimen was the responsibility of each physician&#46;</p><p id="par0085" class="elsevierStylePara elsevierViewall">All DPP4 inhibitor drug treatment was suspended when semaglutide was started&#46;</p><p id="par0090" class="elsevierStylePara elsevierViewall">The recruitment period was from October to December 2019&#46; The data &#40;up to January 2021&#41; were retrospectively collected by the physicians&#46;</p><p id="par0095" class="elsevierStylePara elsevierViewall">The patients started treatment with semaglutide SC in a preloaded pen according to routine clinical practice&#46; The medication was provided by the sponsor&#46; The physician determined the initial dose&#44; the escalation dose&#44; and the maintenance dose as well as any later changes to the maintenance dose&#46;</p><p id="par0100" class="elsevierStylePara elsevierViewall">After visit 1 &#40;0 weeks&#41;&#44; the patients attended visits only if appropriate according to routine clinical practice &#40;at six months and at one year from the start&#41;&#46; Given that the study took place during the COVID-19 pandemic period&#44; body measurement data are not available for all initially recruited individuals&#44; given that many of the intermediate visits were online&#46; Nevertheless&#44; we consider glycated hemoglobin values as the primordial data set as they report on the principal objective &#40;glycemic control&#41;&#46; Patients &#40;n&#160;&#61;&#160;17&#41; who did not have follow-up blood tests performed between weeks 28 and 38 were considered lost to follow-up&#46;</p><p id="par0105" class="elsevierStylePara elsevierViewall">The main study variables were quantitative&#58; HbA1c was measured using high-performance liquid chromatography &#40;HPLC&#41; &#40;Jokoh HS-10 Analyzer&#41;&#46; The initial values were standardizing according to IFCC criteria &#40;JDS&#47;JSCC HbA1c&#160;&#61;&#160;0&#46;927 &#91;IFCC HbA1c&#93;&#160;&#43;&#160;1&#46;73&#41;&#46; Height&#44; weight&#44; and BMI &#40;weight in kg divided by height in meters squared&#41; were measured with the subject wearing light clothing and without shoes&#46; Data on insulin units were gathered by the physician during the medical consultation according to data provided by the patient and subsequent prescriptions&#46;</p></span><span id="sec0030" class="elsevierStyleSection elsevierViewall"><span class="elsevierStyleSectionTitle" id="sect0090">Statistical analysis</span><p id="par0110" class="elsevierStylePara elsevierViewall">We used descriptive statistics &#40;mean&#160;&#177;&#160;standard deviation &#40;SD&#41; for quantitative variables and percentages for categorical variables&#41; to describe patients&#8217; characteristics upon starting semaglutide&#46;</p><p id="par0115" class="elsevierStylePara elsevierViewall">The baseline characteristics were analyzed in the analysis of the total group&#44; which included all patients who started treatment with semaglutide &#40;n&#160;&#61;&#160;117&#41;&#46;</p><p id="par0120" class="elsevierStylePara elsevierViewall">The primary objective &#40;change in HbA1c&#41; was calculated with 95&#37; confidence intervals and two-tailed <span class="elsevierStyleItalic">p</span> values&#46; The secondary and exploratory objectives were calculated in the same manner as the primary objective&#46;</p><p id="par0125" class="elsevierStylePara elsevierViewall">The population for the outcomes analysis was individuals who started treatment with semaglutide and who had data on HbA1c &#40;n&#160;&#61;&#160;100&#41;&#44; weight &#40;n&#160;&#61;&#160;55&#41;&#44; and insulin units &#40;n&#160;&#61;&#160;87&#41; from the end of the study&#46;</p><p id="par0130" class="elsevierStylePara elsevierViewall">The repeated measures ANOVA comparison of means test was used for the statistical analysis&#44; performed using the GraphPad program&#46;</p><p id="par0135" class="elsevierStylePara elsevierViewall">A subgroup analysis was performed based on whether the patient was already in treatment with another GLP-1ra or if it was started at that time &#40;GLP-1ra naive vs&#46; GLP-1ra experienced&#41;&#46;</p></span></span><span id="sec0035" class="elsevierStyleSection elsevierViewall"><span class="elsevierStyleSectionTitle" id="sect0095">Results</span><span id="sec0040" class="elsevierStyleSection elsevierViewall"><span class="elsevierStyleSectionTitle" id="sect0100">Patients&#8217; baseline characteristics</span><p id="par0140" class="elsevierStylePara elsevierViewall">A total of 117 patients were evaluated in the study period&#44; of which 100 &#40;85&#37;&#41; completed follow-up to week 53 &#40;<a class="elsevierStyleCrossRef" href="#tbl0005">Table 1</a>&#41;&#46; The reasons the 17 patients did not complete follow-up were&#58; lack of adherence to medical visits &#40;n&#160;&#61;&#160;9&#41;&#44; adverse effects &#40;n&#160;&#61;&#160;6&#41;&#44; and clinical decision &#40;n&#160;&#61;&#160;2&#41;&#46; The adverse effects which led to the suspension of the drug were gastrointestinal in nature &#40;nausea and vomiting&#41;&#46; The mean age of patients was 64&#46;4&#160;&#177;&#160;9&#46;4 years and 57&#37; were male&#46;</p><elsevierMultimedia ident="tbl0005"></elsevierMultimedia><p id="par0145" class="elsevierStylePara elsevierViewall">The mean baseline HbA1c was 8&#46;31&#37;&#44; the mean duration of diabetes was 16&#46;7 years&#44; and the mean body weight was 97&#46;3&#160;kg&#46;</p><p id="par0150" class="elsevierStylePara elsevierViewall">Patients were prescribed an initial dose of 0&#46;25&#160;mg of semaglutide weekly&#46; At six months from starting treatment&#44; 99 &#40;85&#37;&#41; patients were on a dose of 0&#46;5&#160;mg&#47;week&#44; 11 &#40;9&#37;&#41; were on a dose of 1&#160;mg&#47;week&#44; and 7 &#40;6&#37;&#41; continued with the initial dose of 0&#46;25&#160;mg&#47;week&#46; At the end of follow-up&#44; 55 &#40;47&#37;&#41; patients received a dose of 1&#160;mg&#47;week&#44; 39 &#40;33&#37;&#41; patients received 0&#46;5&#160;mg&#47;week&#44; and 6 &#40;5&#37;&#41; maintained the dose of 0&#46;25&#160;mg&#47;week&#46; At 12 months from starting medical treatment&#44; 6 &#40;6&#37;&#41; continued with the initial dose of 0&#46;25&#160;mg&#47;week&#44; 39 &#40;39&#37;&#41; were on 0&#46;5&#160;mg&#47;week&#44; and 55 &#40;55&#37;&#41; had progressed to the maximum dose of 1&#160;mg&#47;week&#46;</p><p id="par0155" class="elsevierStylePara elsevierViewall">Before starting treatment with semaglutide&#44; 37 &#40;32&#37;&#41; patients were in treatment with another GLP-1ra&#58; 17 patients with liraglutide&#44; 17 with dulaglutide&#44; and 7 with exenatide or lixisenatide&#46;</p><p id="par0160" class="elsevierStylePara elsevierViewall">The mean number of oral antidiabetics &#40;OAD&#41;&#47;patient&#47;day was 1&#46;6&#160;&#177;&#160;1&#46;02&#46; A total of 20 patients &#40;17&#37;&#41; were not taking any OAD&#44; 26 patients &#40;23&#37;&#41; took 1 OAD&#44; 45 &#40;39&#37;&#41; took 2 OAD&#44; 23 &#40;20&#37;&#41; took 3 OAD&#44; and 2 &#40;1&#37;&#41; took 4 OAD&#46; At the start of the study&#44; 91 &#40;78&#37;&#41; patients were taking metformin&#46;</p><p id="par0165" class="elsevierStylePara elsevierViewall">In regard to the insulin regimen prior to starting semaglutide&#44; 49 &#40;42&#37;&#41; patients were only taking basal insulin&#44; 42 &#40;36&#37;&#41; were taking basal-bolus insulin&#44; and 26 &#40;22&#37;&#41; were taking premixed insulin&#46;</p></span><span id="sec0045" class="elsevierStyleSection elsevierViewall"><span class="elsevierStyleSectionTitle" id="sect0105">HbA1c</span><p id="par0170" class="elsevierStylePara elsevierViewall">One hundred of the initial 117 patients completed the study &#40;data at baseline&#44; at six months&#44; and at one year&#41;&#46; At six months from starting weekly semaglutide SC&#44; the mean change in HbA1c was &#8211;0&#46;86&#37; &#40;95&#37; CI&#58; &#8211;0&#46;46&#59; &#8211;1&#46;15&#59; <span class="elsevierStyleItalic">p</span>&#160;&#60;&#160;0&#46;0001&#41; &#40;<a class="elsevierStyleCrossRef" href="#fig0005">Fig&#46; 1</a>&#41;&#46; At 12 months&#44; the decrease in HbA1c was maintained&#46; Therefore&#44; the mean estimated change compared to the baseline figure was &#8211;0&#46;74&#37; &#40;95&#37; CI&#58; &#8211;0&#46;59&#59; &#8211;1&#46;14&#59; <span class="elsevierStyleItalic">p</span>&#160;&#60;&#160;0&#46;0001&#41;&#46; There were no statistically significant differences between data at six and 12 months&#46;</p><elsevierMultimedia ident="fig0005"></elsevierMultimedia><p id="par0175" class="elsevierStylePara elsevierViewall">In the subgroup of GLP-1ra naive patients&#44; the change in HbA1c from the value at baseline to the value at 12 months was slightly less &#40;&#8211;0&#46;94&#37;&#59; 95&#37; CI&#58; &#8211;1&#46;36&#59; &#8211;0&#46;53&#59; <span class="elsevierStyleItalic">p</span>&#160;&#60;&#160;0&#46;0001&#41; than the change in the value at six months &#40;&#8211;1&#46;21&#37;&#41;&#46; Regarding the GLP-1ra experienced group&#44; the difference of &#8211;0&#46;44&#37; &#40;95&#37; CI&#58; &#8211;0&#46;90&#59; 0&#46;02&#59; <span class="elsevierStyleItalic">p</span>&#160;&#61;&#160;0&#46;0616&#41; at 12 months compared to the initial value was not statistically significant&#59; the value at six months was not significant either&#46;</p></span><span id="sec0050" class="elsevierStyleSection elsevierViewall"><span class="elsevierStyleSectionTitle" id="sect0110">Weight</span><p id="par0180" class="elsevierStylePara elsevierViewall">The mean baseline weight was 97&#46;3&#160;&#177;&#160;18&#46;43&#160;kg&#46; Only 55 &#40;47&#46;4&#37;&#41; patients have data available from the study&#8217;s three time points&#46; In general&#44; the mean change in body weight at six months compared to the initial value was &#8211;5&#46;33&#160;kg &#40;95&#37; CI&#58; &#8211;4&#46;25&#59; &#8211;6&#46;42&#59; <span class="elsevierStyleItalic">p</span>&#160;&#60;&#160;0&#46;0001&#41;&#46; The value at 12 months was &#8211;3&#46;61 kg &#40;95&#37; CI&#58; &#8211;2&#46;30&#59; &#8211;4&#46;92&#59; <span class="elsevierStyleItalic">p</span>&#160;&#60;&#160;0&#46;0001&#41; &#40;<a class="elsevierStyleCrossRef" href="#fig0010">Fig&#46; 2</a>&#41;&#46;</p><elsevierMultimedia ident="fig0010"></elsevierMultimedia><p id="par0185" class="elsevierStylePara elsevierViewall">In the subgroup analysis&#44; the initial baseline weight in the GLP-1ra naive group was 95&#46;54&#160;kg &#40;SD 19&#46;21&#41;&#46; At six months from starting semaglutide&#44; a mean decrease of &#8211;5&#46;68&#160;kg was achieved &#40;95&#37; CI&#58; &#8211;4&#46;57&#59; &#8211;7&#46;18&#59; <span class="elsevierStyleItalic">p</span>&#160;&#60;&#160;0&#46;0001&#41; and at 12 months&#44; a mean decrease of &#8211;4&#46;54 kg was achieved &#40;95&#37; CI&#58; &#8211;2&#46;80&#59; &#8211;6&#46;28&#59; <span class="elsevierStyleItalic">p</span>&#160;&#60;&#160;0&#46;0001&#41;&#46; However&#44; the mean baseline weight was higher in the GLP-1ra experienced group&#58; 100&#46;95 kg &#40;SD 16&#46;34&#41;&#46; At six months&#44; a reduction of &#8211;1&#46;01 kg was achieved &#40;95&#37; CI&#58; &#8211;1&#46;21&#59; 3&#46;24&#59; NS&#41; and at 12 months&#44; a reduction of &#8211;2&#46;70 kg was achieved &#40;95&#37; CI&#58; &#8211;0&#46;80&#59; &#8211;4&#46;60&#59; <span class="elsevierStyleItalic">p</span>&#160;&#61;&#160;0&#46;004&#41;&#46;</p></span><span id="sec0055" class="elsevierStyleSection elsevierViewall"><span class="elsevierStyleSectionTitle" id="sect0115">Total insulin dose</span><p id="par0190" class="elsevierStylePara elsevierViewall">The initial total insulin dose was 63&#46;78&#160;&#177;&#160;39&#46;69 IU&#46; Data are available on 87 &#40;75&#37;&#41; patients throughout the study &#40;<a class="elsevierStyleCrossRef" href="#fig0015">Fig&#46; 3</a>&#41;&#46; Compared to the initial value&#44; the mean change in the total population at six months was &#8211;15&#46;18 IU &#40;95&#37; CI&#58; &#8211;10&#46;67&#59; &#8211;19&#46;68&#59; <span class="elsevierStyleItalic">p</span>&#160;&#60;&#160;0&#46;0001&#41; and at 12 months was &#8211;15&#46;88 IU &#40;95&#37; CI&#58; &#8211;10&#46;98&#59; &#8211;20&#46;74&#59; <span class="elsevierStyleItalic">p</span>&#160;&#60;&#160;0&#46;0001&#41;&#46;</p><elsevierMultimedia ident="fig0015"></elsevierMultimedia><p id="par0195" class="elsevierStylePara elsevierViewall">In the subgroup analysis&#44; the initial total dose of insulin in the GLP-1ra naive group was 63&#46;00 &#40;SD 38&#46;64&#41;&#46; At six months from starting semaglutide&#44; a mean reduction of &#8211;18&#46;06 IU was achieved &#40;95&#37; CI&#58; &#8211;12&#46;33&#59; &#8211;23&#46;78&#59; <span class="elsevierStyleItalic">p</span>&#160;&#60;&#160;0&#46;0001&#41; and at 12 months&#44; a mean reduction of 22&#46;21 IU was achieved &#40;95&#37; CI&#58; &#8211;9&#46;32&#59; &#8211;35&#46;10&#59; <span class="elsevierStyleItalic">p</span>&#160;&#60;&#160;0&#46;0001&#41;&#46;</p><p id="par0200" class="elsevierStylePara elsevierViewall">On the contrary&#44; this decrease was less noteworthy in the GLP-1ra experienced subgroup&#46; The total initial dose was 65&#46;46 IU &#40;SD 42&#46;36&#41;&#46; At six months from starting semaglutide&#44; a mean reduction of 8&#46;99 IU was achieved &#40;95&#37; CI&#58; &#8211;2&#46;21&#59; 15&#46;77&#59; <span class="elsevierStyleItalic">p</span>&#160;&#61;&#160;0&#46;008&#41; and at 12 months&#44; a mean reduction of 4&#46;79 IU was achieved &#40;95&#37; CI&#58; &#8211;2&#46;76&#59; 12&#46;24&#59; <span class="elsevierStyleItalic">p</span>&#160;&#61;&#160;0&#46;2935&#41;&#46;</p></span><span id="sec0060" class="elsevierStyleSection elsevierViewall"><span class="elsevierStyleSectionTitle" id="sect0120">Units of insulin&#47;kg of weight</span><p id="par0205" class="elsevierStylePara elsevierViewall">Only 52 &#40;50&#37;&#41; of the 117 patients have data available on IU&#47;kg of weight from the three evaluations&#46; The mean initial figure was 0&#46;67&#160;&#177;&#160;0&#46;44 IU&#47;kg&#46; The mean change at six months compared to the initial value was &#8211;0&#46;14 IU&#47;kg &#40;95&#37; CI&#58; &#8211;0&#46;09&#59; &#8211;0&#46;20&#59; <span class="elsevierStyleItalic">p</span>&#160;&#60;&#160;0&#46;0001&#41;&#46; At 12 months from the start of the study&#44; a mean reduction of &#8211;0&#46;15 IU&#47;kg was achieved &#40;95&#37; CI&#58; &#8211;0&#46;10&#59; &#8211;0&#46;21&#59; <span class="elsevierStyleItalic">p</span>&#160;&#60;&#160;0&#46;0001&#41;&#46;</p><p id="par0210" class="elsevierStylePara elsevierViewall">In the subgroup analysis&#44; the initial figure of IU&#47;kg of weight in the GLP-1ra naive group &#40;n&#160;&#61;&#160;35&#41; was 0&#46;69 IU&#47;kg &#40;SD 0&#46;46&#41;&#46; At six months&#44; a reduction of &#8211;0&#46;19 IU&#47;kg was achieved &#40;95&#37; CI&#58; &#8211;0&#46;12&#59; &#8211;0&#46;25&#59; <span class="elsevierStyleItalic">p</span>&#160;&#60;&#160;0&#46;0001&#41; and at 12 months&#44; this reduction was maintained and increased&#44; reaching &#8211;0&#46;23 IU&#47;kg &#40;95&#37; CI&#58; &#8211;0&#46;16&#59; &#8211;0&#46;30&#59; <span class="elsevierStyleItalic">p</span>&#160;&#60;&#160;0&#46;0001&#41;&#46;</p><p id="par0215" class="elsevierStylePara elsevierViewall">In the GLP-1ra experienced subgroup&#44; the initial mean dose was 0&#46;64 IU&#47;kg of weight &#40;n&#160;&#61;&#160;17&#41;&#46; At six months&#44; a reduction of just &#8211;0&#46;01 IU&#47;kg was achieved &#40;95&#37; CI&#58; &#8211;0&#46;06&#59; 0&#46;08&#59; <span class="elsevierStyleItalic">p</span>&#160;&#62;&#160;0&#46;9999&#41; and at 12 months&#44; a reduction of 0&#46;03 IU was achieved &#40;95&#37; CI&#58; &#8211;0&#46;06&#59; 0&#46;08&#59; <span class="elsevierStyleItalic">p</span>&#160;&#61;&#160;0&#46;4051&#41; &#40;<a class="elsevierStyleCrossRef" href="#tbl0010">Table 2</a>&#41;&#46;</p><elsevierMultimedia ident="tbl0010"></elsevierMultimedia><p id="par0220" class="elsevierStylePara elsevierViewall">No patients reported grade 3 or severe hypoglycemic events during the course of this study&#46; The number of mild or moderate hypoglycemic events was not quantified given that they were not considered clinically relevant&#46;</p></span></span><span id="sec0065" class="elsevierStyleSection elsevierViewall"><span class="elsevierStyleSectionTitle" id="sect0125">Discussion</span><p id="par0225" class="elsevierStylePara elsevierViewall">This work has shown that weekly subcutaneous semaglutide in patients treated with insulin produces a significant reduction in HbA1c&#44; weight&#44; and insulin needs&#46; This reduction was greater in patients who had not previously been treated with another GLP-1ra&#46; The drug was well tolerated and just six &#40;5&#37;&#41; patients needed to withdraw from the study due to adverse effects&#46;</p><p id="par0230" class="elsevierStylePara elsevierViewall">Compared to the Canadian SURE study<a class="elsevierStyleCrossRef" href="#bib0095"><span class="elsevierStyleSup">19</span></a>&#44; published with real-world data on semaglutide added to insulin&#44; the reduction in HbA1c was very similar &#40;&#8211;0&#46;86&#37; vs&#46; &#8211;0&#46;90&#37;&#41;&#44; as was the reduction in body weight &#40;&#8211;5&#46;33&#160;kg vs&#46; &#8211;4&#46;5&#160;kg&#41;&#46; In addition&#44; patients started from an initial weight that was also similar &#40;99&#46;2&#160;kg SURE vs&#46; 97&#46;29&#160;kg in our study&#41;&#46; It is important to note that all patients in this study were in treatment with insulin &#40;during and prior to the study&#41;&#44; but only 41&#37; of patients were treated with insulin in the SURE study &#40;other subgroups were only treated with oral hypoglycemic agents&#41;&#46;</p><p id="par0235" class="elsevierStylePara elsevierViewall">If we compare our data to those obtained in other non-real-world studies<a class="elsevierStyleCrossRefs" href="#bib0085"><span class="elsevierStyleSup">17&#44;18</span></a>&#44; the conclusion is the same&#58; combined insulin and semaglutide treatment significantly improved glycemic control in terms of a reduction in HbA1c and the number of patients within the target &#40;HbA1c &#60;7&#37;&#41;&#44; with associated weight loss&#46;</p><p id="par0240" class="elsevierStylePara elsevierViewall">Overall&#44; our results support the role of semaglutide combined with insulin as a valuable intensification strategy for producing a clinical benefit in the management of DM2&#46; Along these lines&#44; the updated consensus document from the American Diabetes Association and the European Association for the Study of Diabetes &#40;EASD&#41; suggests intensifying treatment with GLP-1ra&#44; among other drugs including SGLT-2is or prandial insulin&#44; in patients who cannot meet glycemic targets at the start of insulin treatment in combination with oral medication<a class="elsevierStyleCrossRef" href="#bib0005"><span class="elsevierStyleSup">1</span></a>&#46;</p><p id="par0245" class="elsevierStylePara elsevierViewall">Due to the disease&#8217;s natural history&#44; many patients with DM2 need insulin to reach their glycemic control target&#46; A common approach for starting insulin therapy is a single injection of basal insulin&#44; which is eventually titrated to optimize treatment<a class="elsevierStyleCrossRef" href="#bib0005"><span class="elsevierStyleSup">1</span></a>&#46; If necessary&#44; treatment intensification to reach the glycemic target can include the addition of one or more rapid-acting insulin doses before meals &#40;basal-plus or basal-bolus regimen&#41; or a change to a premixed insulin regimen in which there is a fixed amount of intermediate-acting or short- or rapid-acting insulin&#46;</p><p id="par0250" class="elsevierStylePara elsevierViewall">Although these regimens lead to a similar decrease in HbA1c levels<a class="elsevierStyleCrossRef" href="#bib0100"><span class="elsevierStyleSup">20</span></a>&#44; there is a certain degree of reluctance to intensifying insulin therapy due to possible adverse effects &#40;i&#46;e&#46;&#44; an increase in the number of hypoglycemic events and weight gain&#41; and practical issues &#40;i&#46;e&#46;&#44; difficulties in educating patients on injection therapy&#41;&#46; In this context&#44; the addition of semaglutide to insulin can be a valid therapeutic option for improving glycemic control and minimizing adverse events associated with insulin intensification&#46;</p><p id="par0255" class="elsevierStylePara elsevierViewall">The subgroup analysis shows that the patients who benefited most from treatment with semaglutide are those not previously treated with another GLP-1ra&#44; i&#46;e&#46;&#44; those who had not been treated with another drug from the same family&#46; Those who had previously been treated with another GLP-1ra had favorable results&#44; especially in terms of weight loss&#44; but not to the same extent in terms of glycemic control&#46;</p><p id="par0260" class="elsevierStylePara elsevierViewall">In conclusion&#44; combined insulin and semaglutide therapy is a valuable treatment strategy for improving metabolic control in the management of DM2<a class="elsevierStyleCrossRef" href="#bib0105"><span class="elsevierStyleSup">21</span></a>&#46;</p></span><span id="sec0070" class="elsevierStyleSection elsevierViewall"><span class="elsevierStyleSectionTitle" id="sect0130">Funding</span><p id="par0265" class="elsevierStylePara elsevierViewall">The authors declare that they have not received funding for conducting this study&#46;</p></span><span id="sec0075" class="elsevierStyleSection elsevierViewall"><span class="elsevierStyleSectionTitle" id="sect0135">Conflicts of interest</span><p id="par0270" class="elsevierStylePara elsevierViewall">The authors declare no conflicts of interest&#46;</p></span></span>"
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    "fechaRecibido" => "2022-02-06"
    "fechaAceptado" => "2022-03-04"
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            0 => "Type 2 diabetes"
            1 => "Weight"
            2 => "Insulin resistance"
            3 => "Glucose control"
            4 => "Follow-up"
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            0 => "Diabetes tipo 2"
            1 => "Peso"
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        "resumen" => "<span id="abst0005" class="elsevierStyleSection elsevierViewall"><span class="elsevierStyleSectionTitle" id="sect0010">Objectives</span><p id="spar0040" class="elsevierStyleSimplePara elsevierViewall">This work aims to determine the real-life anthropometric and analytical benefits of adding subcutaneous semaglutide to previous insulin treatment in patients with type 2 diabetes&#46;</p></span> <span id="abst0010" class="elsevierStyleSection elsevierViewall"><span class="elsevierStyleSectionTitle" id="sect0015">Methods</span><p id="spar0045" class="elsevierStyleSimplePara elsevierViewall">This is a descriptive&#44; retrospective&#44; open-label study describing the clinical and anthropometric characteristics of 117 patients diagnosed with type 2 diabetes followed-up on in the Endocrinology and Nutrition outpatient clinic of the Hospital Universitario Central de Asturias for 53 weeks after starting treatment with subcutaneous semaglutide &#40;October&#8211;December 2019&#41;&#46; All patients were on previous insulin treatment with or without oral antidiabetics&#46;</p></span> <span id="abst0015" class="elsevierStyleSection elsevierViewall"><span class="elsevierStyleSectionTitle" id="sect0020">Results</span><p id="spar0050" class="elsevierStyleSimplePara elsevierViewall">Of the 117 initial patients&#44; 17 did not complete the study due to adverse effects &#40;nausea&#44; vomiting&#41;&#44; the physician&#8217;s decision&#44; or loss to follow-up&#46; Twelve months &#40;week 53&#41; after starting semaglutide&#44; there was a decrease in HbA1c of 0&#46;74&#37; &#40;95&#37; CI 0&#46;59&#8211;1&#46;14&#44; <span class="elsevierStyleItalic">p</span>&#160;&#60;&#160;0&#46;05&#41; as well as 3&#46;61 kg of weight loss &#40;95&#37; CI 2&#46;30&#8211;4&#46;92&#44; <span class="elsevierStyleItalic">p</span>&#160;&#60;&#160;0&#46;05&#41; and a decline in total insulin of 15&#46;88 IU &#40;95&#37; CI 10&#46;98&#8211;20&#46;74&#44; <span class="elsevierStyleItalic">p</span>&#160;&#60;&#160;0&#46;05&#41; from baseline figures&#46; In patients without prior GLP-1 receptor analogs &#40;GLP-1ra&#41;&#44; the effect in terms of a reduction in HbA1c&#44; weight&#44; and the total insulin dose was statistically significant&#46; However&#44; in patients pre-treated with GLP-1ra only had improvements in terms of weight loss&#46; No serious adverse events were observed&#46;</p></span> <span id="abst0020" class="elsevierStyleSection elsevierViewall"><span class="elsevierStyleSectionTitle" id="sect0025">Conclusions</span><p id="spar0060" class="elsevierStyleSimplePara elsevierViewall">The addition of subcutaneous semaglutide to prior insulin treatment with or without oral antidiabetics safely led to a decrease in HbA1c&#44; weight&#44; and the insulin dose&#46; This effect is greater in GLP-1ra naive patients&#46;</p></span>"
        "secciones" => array:4 [
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        "resumen" => "<span id="abst0025" class="elsevierStyleSection elsevierViewall"><span class="elsevierStyleSectionTitle" id="sect0035">Objetivos</span><p id="spar0065" class="elsevierStyleSimplePara elsevierViewall">Determinar en la vida real los beneficios antropom&#233;tricos y anal&#237;ticos de la adici&#243;n de semaglutida por v&#237;a subcut&#225;nea al tratamiento previo con insulina en pacientes con diabetes tipo 2&#46;</p></span> <span id="abst0030" class="elsevierStyleSection elsevierViewall"><span class="elsevierStyleSectionTitle" id="sect0040">M&#233;todos</span><p id="spar0070" class="elsevierStyleSimplePara elsevierViewall">Estudio descriptivo&#44; retrospectivo y abierto en el que se describen caracter&#237;sticas cl&#237;nicas y antropom&#233;tricas de 117 pacientes diagnosticados de diabetes tipo 2 seguidos en las consultas externas de Endocrinolog&#237;a y Nutrici&#243;n del Hospital Universitario Central de Asturias a lo largo de 53 semanas tras el inicio de tratamiento con semaglutida subcut&#225;nea &#40;octubre&#8211;diciembre 2019&#41;&#46; Todos los pacientes estaban en tratamiento previo con insulina&#44; con o sin antidiab&#233;ticos orales&#46;</p></span> <span id="abst0035" class="elsevierStyleSection elsevierViewall"><span class="elsevierStyleSectionTitle" id="sect0045">Resultados</span><p id="spar0075" class="elsevierStyleSimplePara elsevierViewall">De los 117 pacientes iniciales&#44; 17 no completaron el estudio debido a efectos adversos &#40;n&#225;useas&#44; v&#243;mitos&#41;&#44; decisi&#243;n cl&#237;nica y p&#233;rdida de seguimiento&#46; A los 12 meses &#40;semana 53&#41; del inicio de la semaglutida se obtuvo un descenso de HbA1c de 0&#44;74&#37; &#40;IC 95&#37; 0&#44;59&#8211;1&#44;14&#44; p&#160;&#60;&#160;0&#44;05&#41;&#44; as&#237; como de 3&#44;61 kg de peso &#40;IC 95&#37; 2&#44;30&#8211;4&#44;92&#44; p&#160;&#60;&#160;0&#44;05&#41;&#44; y de 15&#44;88 UI de insulina total &#40;IC 95&#37; 10&#44;98&#8211;20&#44;74&#44; p&#160;&#60;&#160;0&#44;05&#41; respecto a las cifras basales&#46; En pacientes sin an&#225;logo del receptor de GLP-1 &#40;arGLP-1&#41; previo&#44; el efecto en la disminuci&#243;n de HbA1c&#44; el peso y la dosis total de insulina fue estad&#237;sticamente significativo&#59; sin embargo&#44; los pacientes pretratados con arGLP-1 solo tuvieron mejor&#237;a en la reducci&#243;n de peso&#46; No se observaron eventos adversos graves&#46;</p></span> <span id="abst0040" class="elsevierStyleSection elsevierViewall"><span class="elsevierStyleSectionTitle" id="sect0050">Conclusiones</span><p id="spar0085" class="elsevierStyleSimplePara elsevierViewall">La adici&#243;n de semaglutida subcut&#225;nea al tratamiento previo con insulina con o sin antidiab&#233;ticos orales induce una disminuci&#243;n de HbA1c&#44; peso y dosis de insulina de forma segura&#46; Este efecto es mayor en pacientes na&#239;ve para tratamiento con arGLP-1&#46;</p></span>"
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        "nota" => "<p class="elsevierStyleNotepara" id="npar0005">Please cite this article as&#58; Ares-Blanco J&#44; Pujante-Alarc&#243;n P&#44; Lambert C&#44; Morales-S&#225;nchez P&#44; Delgado-&#193;lvarez E&#44; Men&#233;ndez-Torre EL&#46; Efectos en vida real de la adici&#243;n de semaglutida subcut&#225;nea semanal al tratamiento con insulina en diabetes mellitus tipo 2&#46; Rev Clin Esp&#46; 2022&#59;222&#58;516&#8211;522&#46;</p>"
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                  \t\t\t\t" class=""><thead title="thead"><tr title="table-row"><th class="td" title="\n
                  \t\t\t\t\ttable-head\n
                  \t\t\t\t  " align="left" valign="\n
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                  \t\t\t\t" scope="col" style="border-bottom: 2px solid black">&nbsp;\t\t\t\t\t\t\n
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                  \t\t\t\t\ttable-head\n
                  \t\t\t\t  " align="left" valign="\n
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                  \t\t\t\t" scope="col" style="border-bottom: 2px solid black">Total&nbsp;\t\t\t\t\t\t\n
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                  \t\t\t\t\ttable-head\n
                  \t\t\t\t  " align="left" valign="\n
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                  \t\t\t\t" scope="col" style="border-bottom: 2px solid black">GLP-1ra naive&nbsp;\t\t\t\t\t\t\n
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                  \t\t\t\t">N &#40;&#37;&#41;&nbsp;\t\t\t\t\t\t\n
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                  \t\t\t\t\ttable-entry\n
                  \t\t\t\t  " align="left" valign="\n
                  \t\t\t\t\ttop\n
                  \t\t\t\t">117&nbsp;\t\t\t\t\t\t\n
                  \t\t\t\t</td><td class="td" title="\n
                  \t\t\t\t\ttable-entry\n
                  \t\t\t\t  " align="left" valign="\n
                  \t\t\t\t\ttop\n
                  \t\t\t\t">80 &#40;69&#41;&nbsp;\t\t\t\t\t\t\n
                  \t\t\t\t</td><td class="td" title="\n
                  \t\t\t\t\ttable-entry\n
                  \t\t\t\t  " align="left" valign="\n
                  \t\t\t\t\ttop\n
                  \t\t\t\t">37 &#40;32&#41;&nbsp;\t\t\t\t\t\t\n
                  \t\t\t\t</td></tr><tr title="table-row"><td class="td-with-role" title="\n
                  \t\t\t\t\ttable-entry\n
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                  \t\t\t\t">Time since onset &#40;years&#41;&nbsp;\t\t\t\t\t\t\n
                  \t\t\t\t</td><td class="td" title="\n
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                  \t\t\t\t  " align="left" valign="\n
                  \t\t\t\t\ttop\n
                  \t\t\t\t">16&#46;64&#160;&#177;&#160;7&#46;99&nbsp;\t\t\t\t\t\t\n
                  \t\t\t\t</td><td class="td" title="\n
                  \t\t\t\t\ttable-entry\n
                  \t\t\t\t  " align="left" valign="\n
                  \t\t\t\t\ttop\n
                  \t\t\t\t">16&#46;08&#160;&#177;&#160;8&#46;52&nbsp;\t\t\t\t\t\t\n
                  \t\t\t\t</td><td class="td" title="\n
                  \t\t\t\t\ttable-entry\n
                  \t\t\t\t  " align="left" valign="\n
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                  \t\t\t\t">17&#46;86&#160;&#177;&#160;6&#46;65&nbsp;\t\t\t\t\t\t\n
                  \t\t\t\t</td></tr><tr title="table-row"><td class="td-with-role" title="\n
                  \t\t\t\t\ttable-entry\n
                  \t\t\t\t ; entry_with_role_rowhead " align="left" valign="\n
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                  \t\t\t\t">Age &#40;years&#41;&nbsp;\t\t\t\t\t\t\n
                  \t\t\t\t</td><td class="td" title="\n
                  \t\t\t\t\ttable-entry\n
                  \t\t\t\t  " align="left" valign="\n
                  \t\t\t\t\ttop\n
                  \t\t\t\t">64&#46;23&#160;&#177;&#160;9&#46;43&nbsp;\t\t\t\t\t\t\n
                  \t\t\t\t</td><td class="td" title="\n
                  \t\t\t\t\ttable-entry\n
                  \t\t\t\t  " align="left" valign="\n
                  \t\t\t\t\ttop\n
                  \t\t\t\t">63&#46;51&#160;&#177;&#160;9&#46;47&nbsp;\t\t\t\t\t\t\n
                  \t\t\t\t</td><td class="td" title="\n
                  \t\t\t\t\ttable-entry\n
                  \t\t\t\t  " align="left" valign="\n
                  \t\t\t\t\ttop\n
                  \t\t\t\t">65&#46;78&#160;&#177;&#160;9&#46;30&nbsp;\t\t\t\t\t\t\n
                  \t\t\t\t</td></tr><tr title="table-row"><td class="td-with-role" title="\n
                  \t\t\t\t\ttable-entry\n
                  \t\t\t\t ; entry_with_role_rowhead " align="left" valign="\n
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                  \t\t\t\t">No&#46; of OAD&nbsp;\t\t\t\t\t\t\n
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                  \t\t\t\t\ttable-entry\n
                  \t\t\t\t  " align="left" valign="\n
                  \t\t\t\t\ttop\n
                  \t\t\t\t">1&#46;62&#160;&#177;&#160;1&#46;02&nbsp;\t\t\t\t\t\t\n
                  \t\t\t\t</td><td class="td" title="\n
                  \t\t\t\t\ttable-entry\n
                  \t\t\t\t  " align="left" valign="\n
                  \t\t\t\t\ttop\n
                  \t\t\t\t">1&#46;63&#160;&#177;&#160;1&#46;09&nbsp;\t\t\t\t\t\t\n
                  \t\t\t\t</td><td class="td" title="\n
                  \t\t\t\t\ttable-entry\n
                  \t\t\t\t  " align="left" valign="\n
                  \t\t\t\t\ttop\n
                  \t\t\t\t">1&#46;62&#160;&#177;&#160;0&#46;86&nbsp;\t\t\t\t\t\t\n
                  \t\t\t\t</td></tr><tr title="table-row"><td class="td-with-role" title="\n
                  \t\t\t\t\ttable-entry\n
                  \t\t\t\t ; entry_with_role_rowhead " align="left" valign="\n
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                  \t\t\t\t\ttable-entry\n
                  \t\t\t\t  " align="left" valign="\n
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                  \t\t\t\t">54 &#40;46&#41;&nbsp;\t\t\t\t\t\t\n
                  \t\t\t\t</td><td class="td" title="\n
                  \t\t\t\t\ttable-entry\n
                  \t\t\t\t  " align="left" valign="\n
                  \t\t\t\t\ttop\n
                  \t\t\t\t">33 &#40;41&#41;&nbsp;\t\t\t\t\t\t\n
                  \t\t\t\t</td><td class="td" title="\n
                  \t\t\t\t\ttable-entry\n
                  \t\t\t\t  " align="left" valign="\n
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                  \t\t\t\t">21 &#40;57&#41;&nbsp;\t\t\t\t\t\t\n
                  \t\t\t\t</td></tr><tr title="table-row"><td class="td-with-role" title="\n
                  \t\t\t\t\ttable-entry\n
                  \t\t\t\t ; entry_with_role_rowhead " align="left" valign="\n
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                  \t\t\t\t\ttable-entry\n
                  \t\t\t\t  " align="left" valign="\n
                  \t\t\t\t\ttop\n
                  \t\t\t\t">97&#46;28&#160;&#177;&#160;18&#46;43&nbsp;\t\t\t\t\t\t\n
                  \t\t\t\t</td><td class="td" title="\n
                  \t\t\t\t\ttable-entry\n
                  \t\t\t\t  " align="left" valign="\n
                  \t\t\t\t\ttop\n
                  \t\t\t\t">95&#46;54&#160;&#177;&#160;19&#46;21&nbsp;\t\t\t\t\t\t\n
                  \t\t\t\t</td><td class="td" title="\n
                  \t\t\t\t\ttable-entry\n
                  \t\t\t\t  " align="left" valign="\n
                  \t\t\t\t\ttop\n
                  \t\t\t\t">100&#46;95&#160;&#177;&#160;16&#46;34&nbsp;\t\t\t\t\t\t\n
                  \t\t\t\t</td></tr><tr title="table-row"><td class="td-with-role" title="\n
                  \t\t\t\t\ttable-entry\n
                  \t\t\t\t ; entry_with_role_rowhead " align="left" valign="\n
                  \t\t\t\t\ttop\n
                  \t\t\t\t">HbA1c &#40;&#37;&#41;&nbsp;\t\t\t\t\t\t\n
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                  \t\t\t\t\ttable-entry\n
                  \t\t\t\t  " align="left" valign="\n
                  \t\t\t\t\ttop\n
                  \t\t\t\t">8&#46;31&#160;&#177;&#160;1&#46;33&nbsp;\t\t\t\t\t\t\n
                  \t\t\t\t</td><td class="td" title="\n
                  \t\t\t\t\ttable-entry\n
                  \t\t\t\t  " align="left" valign="\n
                  \t\t\t\t\ttop\n
                  \t\t\t\t">8&#46;39&#160;&#177;&#160;1&#46;33&nbsp;\t\t\t\t\t\t\n
                  \t\t\t\t</td><td class="td" title="\n
                  \t\t\t\t\ttable-entry\n
                  \t\t\t\t  " align="left" valign="\n
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                  \t\t\t\t">8&#46;13&#160;&#177;&#160;1&#46;32&nbsp;\t\t\t\t\t\t\n
                  \t\t\t\t</td></tr><tr title="table-row"><td class="td-with-role" title="\n
                  \t\t\t\t\ttable-entry\n
                  \t\t\t\t ; entry_with_role_rowhead " align="left" valign="\n
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                  \t\t\t\t">HbA1c &#60;7&#37;&nbsp;\t\t\t\t\t\t\n
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                  \t\t\t\t  " align="left" valign="\n
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                  \t\t\t\t">17 &#40;15&#41;&nbsp;\t\t\t\t\t\t\n
                  \t\t\t\t</td><td class="td" title="\n
                  \t\t\t\t\ttable-entry\n
                  \t\t\t\t  " align="left" valign="\n
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                  \t\t\t\t">8 &#40;10&#41;&nbsp;\t\t\t\t\t\t\n
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                  \t\t\t\t\ttable-entry\n
                  \t\t\t\t  " align="left" valign="\n
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                  \t\t\t\t">9 &#40;24&#41;&nbsp;\t\t\t\t\t\t\n
                  \t\t\t\t</td></tr><tr title="table-row"><td class="td-with-role" title="\n
                  \t\t\t\t\ttable-entry\n
                  \t\t\t\t ; entry_with_role_rowhead " align="left" valign="\n
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                  \t\t\t\t\ttable-entry\n
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                  \t\t\t\t">63&#46;78&#160;&#177;&#160;39&#46;69&nbsp;\t\t\t\t\t\t\n
                  \t\t\t\t</td><td class="td" title="\n
                  \t\t\t\t\ttable-entry\n
                  \t\t\t\t  " align="left" valign="\n
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                  \t\t\t\t">63&#46;00&#160;&#177;&#160;38&#46;64&nbsp;\t\t\t\t\t\t\n
                  \t\t\t\t</td><td class="td" title="\n
                  \t\t\t\t\ttable-entry\n
                  \t\t\t\t  " align="left" valign="\n
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                  \t\t\t\t">65&#46;46&#160;&#177;&#160;42&#46;36&nbsp;\t\t\t\t\t\t\n
                  \t\t\t\t</td></tr><tr title="table-row"><td class="td-with-role" title="\n
                  \t\t\t\t\ttable-entry\n
                  \t\t\t\t ; entry_with_role_rowhead " align="left" valign="\n
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                  \t\t\t\t\ttable-entry\n
                  \t\t\t\t  " align="left" valign="\n
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                  \t\t\t\t">44&#46;29&#160;&#177;&#160;21&#46;33&nbsp;\t\t\t\t\t\t\n
                  \t\t\t\t</td><td class="td" title="\n
                  \t\t\t\t\ttable-entry\n
                  \t\t\t\t  " align="left" valign="\n
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                  \t\t\t\t">42&#46;85&#160;&#177;&#160;20&#46;23&nbsp;\t\t\t\t\t\t\n
                  \t\t\t\t</td><td class="td" title="\n
                  \t\t\t\t\ttable-entry\n
                  \t\t\t\t  " align="left" valign="\n
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                  \t\t\t\t  " align="left" valign="\n
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                  \t\t\t\t">25&#46;69&#160;&#177;&#160;19&#46;49&nbsp;\t\t\t\t\t\t\n
                  \t\t\t\t</td><td class="td" title="\n
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                  \t\t\t\t  " align="left" valign="\n
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                  \t\t\t\t">0&#46;64&#160;&#177;&#160;0&#46;39&nbsp;\t\t\t\t\t\t\n
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Article information
ISSN: 22548874
Original language: English
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