Efficacy and Safety of Sotagliflozin Versus Placebo in Participants With Type 2 Diabetes Mellitus on Background of Sulfonylurea Alone or With 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
• Sulfonylurea — DRUG
  Pharmaceutical form: tablet Route of administration: oral

Study Details

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.

Key Dates

Start date

Feb 24, 2017

Status verified

Apr 2021

Primary completion

Apr 17, 2019

Completion

Apr 30, 2019

Study Design

Enrollment

507 participants (actual)

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Arms

• Experimental: Sotagliflozin 400 mg
  Following a 2-week run-in phase, participants received two Sotagliflozin tablets of 200 mg, orally once daily, before the first meal of the day plus Metformin and Sulfonylurea as prescribed for up to 26 weeks in the Core Treatment Period. Participants were eligible to continue treatment in the Extension Period. The total treatment duration was planned for up to 79 weeks.
• Placebo Comparator: Placebo
  Following a 2-week run-in period, participants were randomized to matching placebo administered as 2 tablets, once daily, before the first meal of the day plus Metformin and Sulfonylurea as prescribed for up to 26 weeks in the Core Treatment Period. Participants were eligible to continue treatment in the Extension Period. The total treatment duration was planned for up to 79 weeks.

Primary Outcome Measure

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

Locations (28)

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