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

Conditions

• Type 2 Diabetes Mellitus

Eligibility Criteria

Sex

ALL

Age

18 Years - N/A

Healthy Volunteers

Not accepted

Interventions

• Sotagliflozin (SAR439954) — DRUG
  Pharmaceutical form: tablet. Route of administration: oral.
• Placebo — DRUG
  Pharmaceutical form: tablet. Route of administration: oral.
• Metformin — DRUG
  Pharmaceutical form: tablet. Route of administration: oral.

Study Details

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.

Key Dates

Start date

Nov 30, 2016

Status verified

Apr 2021

Primary completion

Feb 26, 2019

Completion

Mar 22, 2019

Study Design

Enrollment

518 participants (actual)

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Arms

• Experimental: Sotagliflozin 400 mg + Metformin
  Following a 2-week run-in period, sotagliflozin 400 mg was administered as 2 tablets, once daily, before the first meal of the day plus metformin as prescribed by the Principal Investigator for up to 26 weeks in the double-blind Core Treatment Period, and participants continued the same treatment in the double-blind Extension Period for up to 53 weeks.
• Placebo Comparator: Placebo + Metformin
  Following a 2-week run-in period, matching placebo was administered as 2 tablets, once daily, before the first meal of the day plus metformin as prescribed by the Principal Investigator for up to 26 weeks in the double-blind Core Treatment Period, and participants continued the same treatment in the double-blind Extension Period for up to 53 weeks.

Primary Outcome Measure

Change From Baseline in Hemoglobin A1c (HbA1c) at Week 26 [ Time Frame: Baseline and Week 26 ]

Locations (67)

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