Efficacy and Safety of Sotagliflozin in Young Adult Patients With Type 1 Diabetes Mellitus and Elevated Hemoglobin A1C

Summary

This Phase 2 study was intended to demonstrate superiority of sotagliflozin versus placebo on Hemoglobin A1C (A1C) reduction at Week 12 in young adult participants with type 1 diabetes mellitus (T1DM) who have poor glycemic control on their current insulin regimen.

Timeline

Start

2015-04

Primary completion

2016-09

Completion

2016-09

Publications

• Bode BW, Cengiz E, Wadwa RP, Banks P, Danne T, Kushner JA, McGuire DK, Peters AL, Strumph P, Sawhney S. Effects of Sotagliflozin Combined with Intensive Insulin Therapy in Young Adults with Poorly Controlled Type 1 Diabetes: The JDRF Sotagliflozin Study. Diabetes Technol Ther. 2021 Jan;23(1):59-69. doi: 10.1089/dia.2020.0079.

Drugs

Indications