drugset / Trial / NCT03351478

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

NCT03351478

Phase 3 Completed 770 enrolled Lexicon Pharmaceuticals Sanofi · collab
RandomizedParallel-groupDouble-blindTreatment

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

Drugs

EvaluationDrugModalityDoseRoute
Comparator Empagliflozin Small molecule 25 mg
Subject Sotagliflozin Small molecule 400 mg