drugset / Trial / NCT03386344

Efficacy and Bone Safety of Sotagliflozin 400 and 200 mg Versus Placebo in Participants With Type 2 Diabetes Mellitus Who Have Inadequate Glycemic Control

NCT03386344

Phase 3 Terminated 376 enrolled Lexicon Pharmaceuticals Sanofi · collab
RandomizedParallel-groupQuadruple-blindTreatment

Summary

The primary objective is to demonstrate the superiority of Sotagliflozin 400 milligrams (mg) versus placebo with respect to hemoglobin A1c (Hb1Ac) reduction in participants with type 2 diabetes (T2D) who have inadequate glycemic control on diet and exercise only or with a stable antidiabetes regimen.

Timeline

Start
2018-02-19
Primary completion
2019-05-22
Completion
2020-05-30

Drugs

EvaluationDrugModalityDoseRoute
Subject Sotagliflozin Small molecule 200 mg Oral
Subject Sotagliflozin Small molecule 400 mg Oral