Sotagliflozin in Combination With Optimized Insulin Therapy in Adults With Type 1 Diabetes: The North American inTandem1 Study.

ABSTRACT:

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 inTandem1 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 400 mg (n = 262) after 6 weeks of insulin optimization. The primary end point was HbA_1c change from baseline at 24 weeks. HbA_1c, weight, and safety were also assessed through 52 weeks.

Results

From a mean baseline of 7.57%, placebo-adjusted HbA_1c reductions were 0.36% and 0.41% with sotagliflozin 200 and 400 mg, respectively, at

SUBMITTER: Buse JB 

PROVIDER: S-EPMC6105319 | biostudies-literature | 2018 Sep

REPOSITORIES: biostudies-literature