Last updated on February 2019

Efficacy and Safety of Sotagliflozin Versus Glimepiride and Placebo in Subjects With Type 2 Diabetes Mellitus That Are Taking Metformin Monotherapy


Brief description of study

Primary Objective:

To demonstrate the non-inferiority of sotagliflozin dose 1 compared to glimepiride on HbA1c (glycosylated A1c) reduction in patients with T2D (type 2 diabetes) who have inadequate glycemic control with metformin.

Secondary Objectives:

To demonstrate the superiority of sotagliflozin dose 1 compared to glimepiride on change in body weight, SBP (systolic blood pressure) in patients with baseline SBP 130 mmHg, SBP in all patients, and proportion of patients with at least 1 documented symptomatic hypoglycemic event (70 mg/dL).

  • To demonstrate the superiority of sotagliflozin dose 1 compared to placebo on change in HbA1c, body weight, SBP in patients with baseline SBP 130 mmHg, SBP in all patients.
  • To demonstrate the superiority of sotagliflozin dose 2 compared to placebo on change in HbA1c.
  • To demonstrate the non-inferiority of sotagliflozin dose 2 compared to glimepiride on change in HbA1c.
  • To demonstrate the superiority of sotagliflozin dose 1 compared to glimepiride on change in HbA1c.
  • To evaluate the safety and tolerability of sotagliflozin compared to glimepiride and placebo.

Detailed Study Description

Up to 58 weeks, including a Screening Period consisting of a Screening phase of up to 2 weeks, a 2-week single-blind placebo Run-in phase, a 52-week double-blind Treatment Period, and a 2-week post-treatment Follow-up period to collect safety information.

Clinical Study Identifier: NCT03332771

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Birmingham, AL United States

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Little Rock, AR United States

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Anaheim, CA United States

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Carmichael, CA United States

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Greenbrae, CA United States

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Huntington Park, CA United States

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Lomita, CA United States

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Long Beach, CA United States

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Los Angeles, CA United States

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Rancho Cucamonga, CA United States

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Sacramento, CA United States

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Van Nuys, CA United States

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Bradenton, FL United States

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Coral Gables, FL United States

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Chicago, IL United States

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Lampasas, TX United States

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Lufkin, TX United States

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McAllen, TX United States

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Plano, TX United States

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Colorado Springs, CO United States

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West Palm Beach, FL United States

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Springfield, IL United States

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Topeka, KS United States

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Baltimore, MD United States

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Olive Branch, MS United States

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Norfolk, NE United States

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Las Vegas, NV United States

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Kecskemet, Hungary

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Salisbury, NC United States

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Ogden, UT United States

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Sofia, Bulgaria

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Balatonfured, Hungary

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Budapest, Hungary

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Nyiregyhaza, Hungary

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Bardejov, Slovakia

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Bratislava, Slovakia

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Mesquite, TX United States

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Richmond, VA United States

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Varna, Bulgaria

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Pembroke Pines, FL United States

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Lemon Grove, CA United States

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Nyíregyháza, Hungary

Recruitment Status: Closed


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