Overview

Efficacy and Safety of Sotagliflozin Versus Placebo in Participants With Type 2 Diabetes Mellitus on Background of Sulfonylurea Alone or With Metformin

Status:
Completed

Trial end date:
2019-04-30

Target enrollment:

Participant gender:

Summary

Primary Objective: To demonstrate the superiority of Sotagliflozin 400 milligrams (mg) versus placebo on Hemoglobin A1c (HbA1c) reduction at Week 26 in participant with type 2 diabetes (T2D) who have inadequate glycemic control with a Sulfonylurea alone or in combination with Metformin. Secondary Objectives: - To compare Sotagliflozin 400 mg versus placebo based on: - Change from baseline in fasting plasma glucose (FPG). - Change from baseline in systolic blood pressure (SBP) for participants with baseline SBP ≥130 millimeter of mercury (mm Hg). - Change from baseline in SBP for all participants. - Change from baseline in body weight. - Percentage of participants with HbA1c <6.5% and <7.0%. - To evaluate the safety of Sotagliflozin 400 mg versus placebo throughout the 79-week trial.

Phase:

Phase 3

Details

Lead Sponsor:

Lexicon Pharmaceuticals
Sanofi

Collaborator:

Sanofi

Treatments:

(2S,3R,4R,5S,6R)-2-(4-chloro-3-(4-ethoxybenzyl)phenyl)-6-(methylthio)tetrahydro-2H-pyran-3,4,5-triol
Metformin