NCT02926950

Efficacy and Safety of Sotagliflozin Versus Placebo in Patients With Type 2 Diabetes Mellitus on Background of Metformin

A Randomized, Double-blind, Placebo-controlled, Parallel-group, Multicenter Study to Evaluate the Efficacy and Safety of Sotagliflozin Added to Metformin in Patients With Type 2 Diabetes Mellitus Who Have Inadequate Glycemic Control on Metformin

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 518 (actual)
• Sponsor: Lexicon Pharmaceuticals · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

Primary Objective: 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 with metformin. Secondary Objectives: * To compare Sotagliflozin versus placebo for. * 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 of mercury (mmHg). * Change from baseline in SBP for all participants. * Change from baseline in body weight. * Proportion of participants with HbA1c \<6.5% and \<7.0%. * To evaluate the safety of Sotagliflozin versus placebo.

Detailed description

The duration of the study period is up to 87 weeks, including a Screening Period consisting of a Screening phase of up to 2 weeks and a 2 week single blind Run-in phase, a 26 week double-blind Core Treatment Period, a 53-week double-blind Extension Period, a 4 week post treatment Follow-up period to collect safety information.

Conditions

• Type 2 Diabetes Mellitus

Interventions

Type	Name	Description
DRUG	Sotagliflozin (SAR439954)	Pharmaceutical form: tablet. Route of administration: oral.
DRUG	Placebo	Pharmaceutical form: tablet. Route of administration: oral.
DRUG	Metformin	Pharmaceutical form: tablet. Route of administration: oral.

Timeline

• Start date: 2016-11-01
• Primary completion: 2019-02-26
• Completion: 2019-03-22
• First posted: 2016-10-06
• Last updated: 2021-05-11
• Results posted: 2021-05-11

Locations

93 sites across 4 countries: United States, Canada, Hungary, Slovakia

Regulatory

• FDA-regulated drug study