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.
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
399
Pharmaceutical form: tablet; Route of administration: oral
Pharmaceutical form: tablet; Route of administration: oral
Investigational Site Number 8401049
Tucson, Arizona, United States
Investigational Site Number 8401026
Tucson, Arizona, United States
Investigational Site Number 8401028
Anaheim, California, United States
Investigational Site Number 8401057
Canoga Park, California, United States
Investigational Site Number 8401058
Garden Grove, California, United States
Change From Baseline in Hemoglobin A1c (HbA1c) at Week 26 (Sotagliflozin 400 mg Versus Placebo)
An analysis of covariance (ANCOVA) model was used for the analysis.
Time frame: Baseline to Week 26
Change From Baseline in 2-hour Postprandial Plasma Glucose (PPG) Following a Mixed Meal at Week 26 (Sotagliflozin 400 mg Versus Placebo)
An ANCOVA model was used for the analysis.
Time frame: Baseline to Week 26
Change From Baseline in 2-hour Postprandial Plasma Glucose (PPG) Following a Mixed Meal at Week 26 (Sotagliflozin 200 mg Versus Placebo)
An ANCOVA model was used for the analysis.
Time frame: Baseline to Week 26
Change From Baseline in Fasting Plasma Glucose (FPG) at Week 26 (Sotagliflozin 400 mg Versus Placebo)
An ANCOVA model was used for the analysis.
Time frame: Baseline to Week 26
Change From Baseline in Systolic Blood Pressure (SBP) at Week 12 in Participants With Baseline SBP ≥130 Millimeter of Mercury (mmHg) (Sotagliflozin 400 mg Versus Placebo)
An ANCOVA model was used for the analysis.
Time frame: Baseline to Week 12
Change From Baseline in SBP at Week 12 for All Participants (Sotagliflozin 400 mg Versus Placebo)
An ANCOVA model was used for the analysis.
Time frame: Baseline to Week 12
Change From Baseline in SBP at Week 12 for All Participants (Sotagliflozin 200 mg Versus Placebo)
An ANCOVA model was used for the analysis.
Time frame: Baseline to Week 12
Change From Baseline in Body Weight at Week 26 (Sotagliflozin 400 mg Versus Placebo)
An ANCOVA model was used for the analysis.
Time frame: Baseline to Week 26
Change From Baseline in Body Weight at Week 26 (Sotagliflozin 200 mg Versus Placebo)
An ANCOVA model was used for the analysis.
Time frame: Baseline to Week 26
Percentage of Participants With HbA1c <6.5% at Week 26 (Sotagliflozin 400 mg Versus Placebo)
Time frame: Week 26
Percentage of Participants With HbA1c <7.0% at Week 26 (Sotagliflozin 400 mg Versus Placebo)
Time frame: Week 26
Change From Baseline in HbA1c at Week 26 (Sotagliflozin 200 mg Versus Placebo)
An ANCOVA model was used for the analysis.
Time frame: Baseline to Week 26
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Investigational Site Number 8401029
Hawaiian Gardens, California, United States
Investigational Site Number 8401017
Huntington Park, California, United States
Investigational Site Number 8401056
Long Beach, California, United States
Investigational Site Number 8401013
Long Beach, California, United States
Investigational Site Number 8401063
Los Angeles, California, United States
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