دورية أكاديمية
Sotagliflozin in combination with optimized insulin therapy in adults with type 1 diabetes: The North American in Tandem1 study
| العنوان: | Sotagliflozin in combination with optimized insulin therapy in adults with type 1 diabetes: The North American in Tandem1 study |
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| المؤلفون: | Buse, J.B., Garg, S.K., Rosenstock, J., Bailey, T.S., Banks, P., Bode, B.W., Danne, T., Kushner, J.A., Lane, W.S., Lapuerta, P., McGuire, D.K., Peters, A.L., Reed, J., Sawhney, S., Strumph, P. |
| المصدر: | Diabetes Care, 41(9) |
| بيانات النشر: | American Diabetes Association Inc. |
| سنة النشر: | 2018 |
| المجموعة: | Carolina Digital Repository (UNC - University of North Carolina) |
| مصطلحات موضوعية: | Adult, Diabetes Mellitus, Type 1, Glycosides, Hypoglycemia, Diabetic Ketoacidosis, North America, Male, Weight Loss, Female, Insulin Infusion Systems, Aged, Humans, Middle Aged, Glycated Hemoglobin A, Drug Therapy, Combination, Body Weight, Double-Blind Method, Insulin |
| الوصف: | OBJECTIVE: Evaluate the efficacy and safety of the dual sodium-glucose cotransporter 1 (SGLT1) and SGLT2 inhibitor sotagliflozin in combination with optimized insulin in type 1 diabetes (T1D). RESEARCH DESIGN AND METHODS: The in Tandem1 trial, a double-blind, 52-week phase 3 trial, randomized North American adults with T1D to placebo (n = 268), sotagliflozin 200 mg (n = 263), or sotagliflozin 400mg(n =262) after6 weeks ofinsulin optimization. The primary end point was HbA1c change from baseline at 24 weeks. HbA1c, weight, and safety were also assessed through 52 weeks. RESULTS: From a mean baseline of 7.57%, placebo-adjusted HbA1c reductions were 0.36% and 0.41% with sotagliflozin 200 and 400 mg, respectively, at 24 weeks and 0.25% and 0.31% at 52 weeks (all P < 0.001). Among patients with a baseline HbA1c ≥7.0%, an HbA1c <7% was achieved by 15.7%, 27.2%, and 40.3% of patients receiving placebo, sotagliflozin 200 mg, and sotagliflozin 400 mg, respectively (P ≤ 0.003 vs. placebo) at 24 weeks. At 52 weeks, mean treatment differences between sotagliflozin 400 mg and placebo were 21.08 mmol/L for fasting plasma glucose, 24.32 kg for weight, and 215.63% for bolus insulin dose and 211.87% for basal insulin dose (all P < 0.001). Diabetes Treatment Satisfaction Questionnaire scores increased significantly by 2.5 points with sotagliflozin versus placebo (P < 0.001) at 24 weeks. Genital mycotic infections and diarrhea occurred more frequently with sotagliflozin. Adjudicated diabetic ketoacidosis (DKA) occurred in 9 (3.4%) and 11 (4.2%) patients receiving sotagliflozin 200 and 400 mg, respectively, and in 1 (0.4%) receiving placebo. Severe hypoglycemia occurred in 17 (6.5%) patients from each sotagliflozin group and 26 (9.7%) patients receiving placebo. CONCLUSIONS: In a 1-year T1D study, sotagliflozin combined with optimized insulin therapy was associated with sustained HbA1c reduction, weight loss, lower insulin dose, fewer episodes of severe hypoglycemia, improved patient-reported outcomes, and more DKA ... |
| نوع الوثيقة: | article in journal/newspaper |
| اللغة: | English |
| العلاقة: | https://doi.org/10.17615/88k1-rx27Test; https://cdr.lib.unc.edu/downloads/wd376281n?file=thumbnailTest; https://cdr.lib.unc.edu/downloads/wd376281nTest |
| DOI: | 10.17615/88k1-rx27 |
| الإتاحة: | https://doi.org/10.17615/88k1-rx27Test https://cdr.lib.unc.edu/downloads/wd376281n?file=thumbnailTest https://cdr.lib.unc.edu/downloads/wd376281nTest |
| حقوق: | http://rightsstatements.org/vocab/InC/1.0Test/ |
| رقم الانضمام: | edsbas.317C606 |
| قاعدة البيانات: | BASE |
| DOI: | 10.17615/88k1-rx27 |
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