Efficacy and Safety of Sotagliflozin Versus Placebo and Empagliflozin in Participants With Type 2 Diabetes Mellitus Who Have Inadequate Glycemic Control While Taking a DPP4 Inhibitor Alone or With Metformin

Summary

The purpose of the study is to demonstrate the superiority of sotagliflozin versus placebo on hemoglobin A1c (HbA1c) reduction in participants with type 2 diabetes (T2D) who have inadequate glycemic control on a DPP4(i) with or without metformin.

Timeline

Start

2017-11-27

Primary completion

2019-05-16

Completion

2019-05-16

Outcome

Met primary endpoint

registry analysis (superiority test); Sotagliflozin 400 mg vs Placebo; p < 0.0001; Difference in Least Square (LS) Means -0.43 (95% CI -0.62 to -0.25); ANCOVA NCT03351478 ↗

Drugs

Indications