Overview

Efficacy and Safety of Sotagliflozin Versus Placebo in Patients With Type 2 Diabetes Mellitus Not Currently Treated With Antidiabetic Therapy

Status:
Completed

Trial end date:
2019-05-17

Target enrollment:

Participant gender:

Summary

Primary Objective: To demonstrate the superiority of Sotagliflozin 400 milligrams (mg) versus placebo on hemoglobin A1c (HbA1c) reduction in participants with type 2 diabetes (T2D) who have inadequate glycemic control on diet and exercise. Secondary Objectives: - To compare Sotagliflozin 400 mg versus placebo based on: - Change from baseline in 2-hour postprandial glucose (PPG) following a mixed meal. - Change from baseline in fasting plasma glucose (FPG). - Change from baseline in systolic blood pressure (SBP) for participants with baseline SBP ≥130 millimeter per mercury (mmHg). - Change from baseline in SBP for all participants. - Change from baseline in body weight. - Proportion of participants with HbA1c <6.5%, <7.0%. - To compare Sotagliflozin 200 mg versus placebo based on: - Change from baseline in HbA1c. - Change from baseline in 2-hour postprandial glucose (PPG) following a mixed meal. - Change from baseline in body weight. - Change from baseline in SBP for all participants. - To evaluate the safety of Sotagliflozin 400 and 200 mg versus placebo.

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