Last updated on October 2017

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


Brief description of study

Primary Objective: To demonstrate the superiority of sotagliflozin dose 1 versus placebo on hemoglobin A1c (HbA1c) reduction in patients with type 2 diabetes (T2D) who have inadequate glycemic control on diet and exercise. Secondary Objectives: - To compare sotagliflozin dose 1 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 patients with baseline SBP ≥130 mmHg; - Change from baseline in SBP for all patients; - Change from baseline in body weight; - Proportion of patients with HbA1c <6.5%, <7.0%. - To compare sotagliflozin dose 2 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 patients. - To evaluate the safety of sotagliflozin doses 1 and 2 versus placebo.

Detailed Study Description

Up to 34 weeks, including a Screening Period consisting of a Screening Phase of up to 2 weeks and a 2-week single-blind placebo Run-in Phase, a 26-week double-blind Treatment Period, and a 4-week post-treatment Follow-up visit to collect safety information.

Clinical Study Identifier: NCT02926937

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