Efficacy and safety of adding sotagliflozin, a dual sodium‐glucose co‐transporter (SGLT)1 and SGLT2 inhibitor, to optimized insulin therapy in adults with type 1 diabetes and baseline body mass index ≥27kg/m2

• Published in: Diabetes, obesity & metabolism obesity & metabolism, 2021-03, Vol.23 (3), p.854-860
• Main Authors: Danne, Thomas, Edelman, Steven, Juan Pablo Frias, Francisco Javier Ampudia‐Blasco, Banks, Philip, Jiang, Wenjun, Davies, Michael J, Sawhney, Sangeeta
• Format: Article
• Language: English
• Subjects: Blood pressure; Body mass index; Body weight; Body weight gain; Clinical trials; Diabetes; Diabetes mellitus (insulin dependent); Diabetic ketoacidosis; Glucose; Glucose monitoring; Glucose transporter; Hemoglobin; Hypoglycemia; Insulin; Ketoacidosis; Overweight; Placebos
• ISSN: 1462-8902; 1463-1326
• DOI: 10.1111/dom.14271

Sotagliflozin, a dual sodium‐glucose co‐transporter (SGLT)1/SGLT2 inhibitor, is currently approved in Europe as an adjunct to optimal insulin therapy in adults with type 1 diabetes (T1D) and a body mass index (BMI) ≥ 27 kg/m2. In this post hoc analysis, efficacy at 24 weeks and safety at 52 weeks from pooled phase 3 clinical trials were evaluated in patients with baseline BMI ≥ 27 kg/m2. Sotagliflozin 200 mg and 400 mg added to insulin reduced glycated haemoglobin level and increased time in range assessed by continuous glucose monitoring versus placebo and also reduced body weight and systolic blood pressure. Differences in efficacy endpoints between sotagliflozin and placebo tended to be greater among patients with BMI ≥ 27 kg/m2 compared to those with baseline BMI