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

Type 2 Diabetes Mellitus Clinical Trial

Official title: A Randomized, Double-blind, Placebo-controlled, Parallel-group, Multicenter Study to Evaluate the Efficacy and Safety of Sotagliflozin Added to a Sulfonylurea Alone or in Combination With Metformin in Patients With Type 2 Diabetes Who Have Inadequate Glycemic Control on a Sulfonylurea Alone or With Metformin

Status Completed

Clinical Trial 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.

Clinical Trial Description

The duration per participants is up to 85 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, and a 2-week post treatment Follow-up period to collect safety information. ;

Related Conditions & MeSH terms

• Diabetes Mellitus
• Diabetes Mellitus, Type 2
• Type 2 Diabetes Mellitus

• NCT number: NCT03066830
• Study type: Interventional
• Source: Lexicon Pharmaceuticals
• Status: Completed
• Phase: Phase 3
• Start date: February 24, 2017
• Completion date: April 30, 2019