At a glance
ClinicalIndex Comparison RecordStandardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
A Randomized, Double-blind, Placebo-controlled, Parallel-group, Multicenter Study to Evaluate the Efficacy and Safety of Sotagliflozin as Monotherapy in Patients With Type 2 Diabetes Mellitus Who Have Inadequate Glycemic Control
In Brief
A Phase 3 clinical trial evaluating Sotagliflozin (SAR439954) and Placebo for Type 2 Diabetes Mellitus. Completed, enrolled 399 participants across 70 sites in 3 countries.
Detailed 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.
Study Details
Timeline
Interventions
Pharmaceutical form: tablet; Route of administration: oral
Pharmaceutical form: tablet; Route of administration: oral