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.
The duration per participants is up to 85 weeks, including a Screening Period consisting of a Screening phase of up to 2 weeks and a 2-week single-blind Run-in phase, a 26-week double blind Core Treatment Period, a 53 week double blind Extension, and a 2-week post treatment Follow-up period to collect safety information.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
507
Pharmaceutical form: tablet Route of administration: oral
Pharmaceutical form: tablet Route of administration: oral
Pharmaceutical form: tablet Route of administration: oral
Pharmaceutical form: tablet Route of administration: oral
Investigational Site Number 8403003
Litchfield Park, Arizona, United States
Investigational Site Number 8403018
Peoria, Arizona, United States
Investigational Site Number 8403009
Greenbrae, California, United States
Investigational Site Number 8403012
Huntington Park, California, United States
Investigational Site Number 8403019
Los Angeles, California, United States
Change From Baseline in Hemoglobin A1c (HbA1c) at Week 26
Missing data are imputed using the retrieved dropouts imputation method. An analysis of covariance (ANCOVA) model was used for the analysis.
Time frame: Baseline to Week 26
Change From Baseline in Fasting Plasma Glucose (FPG) at Week 26
Missing data are imputed using the retrieved dropouts imputation method. An ANCOVA model was used for the analysis.
Time frame: Baseline to Week 26
Change From Baseline in Systolic Blood Pressure (SBP) for Participants With Baseline SBP ≥130 mmHg
Missing data are imputed using the washout imputation method under the missing, not at random framework. 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
Missing data are imputed using washout imputation method under the missing not at random framework. An ANCOVA model was used for the analysis.
Time frame: Baseline to Week 12
Change From Baseline in Body Weight at Week 26
Missing data are imputed using the retrieved dropouts imputation method. An ANCOVA model was used for the analysis.
Time frame: Baseline to Week 26
Percentage of Participants With HbA1c <6.5% at Week 26
Time frame: Week 26
Percentage of Participants With HbA1c <7.0% at Week 26
Time frame: Week 26
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Investigational Site Number 8403034
Montclair, California, United States
Investigational Site Number 8403016
Spring Valley, California, United States
Investigational Site Number 8403014
Tustin, California, United States
Investigational Site Number 8403001
Northglenn, Colorado, United States
Investigational Site Number 8403029
Bradenton, Florida, United States
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