The primary objective is to demonstrate the superiority of Sotagliflozin 400 milligrams (mg) versus placebo with respect to hemoglobin A1c (Hb1Ac) reduction in participants with type 2 diabetes (T2D) who have inadequate glycemic control on diet and exercise only or with a stable antidiabetes regimen.
Study duration per participant is approximately 110 weeks (Screening period of up to 2 weeks, 2 week single-blind run-in period), a 26-week double-blind core treatment period, a 78-week double-blind extension period, and a 2- week post treatment follow up period. Dual-energy X-ray absorptiometry (DXA) scans will be performed to assess Bone Mineral Density and Fat vs. Lean body mass at baseline and Weeks 26, 52, and 104.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
376
Pharmaceutical form: Tablet; Route of administration: Oral
Pharmaceutical form: Tablet; Route of administration: Oral
Change From Baseline in Hemoglobin A1c (HbA1c) at Week 26
An analysis of covariance (ANCOVA) model is used for analysis.
Time frame: Baseline to Week 26
Percent Change From Baseline in Bone Mineral Density (BMD) of Lumbar Spine at Week 26
An ANCOVA model is used for analysis.
Time frame: Baseline to Week 26
Percent Change From Baseline in Bone Mineral Density (BMD) of Total Hip at Week 26
An ANCOVA model is used for analysis.
Time frame: Baseline to Week 26
Percent Change From Baseline in Bone Mineral Density (BMD) of Femoral Neck at Week 26
An ANCOVA model is used for analysis.
Time frame: Baseline to Week 26
Change From Baseline in Body Weight at Week 26
An ANCOVA model is used for analysis.
Time frame: Baseline to Week 26
Change From Baseline in Fasting Plasma Glucose (FPG) at Week 26
An ANCOVA model is used for analysis.
Time frame: Baseline to Week 26
Change From Baseline in Systolic Blood Pressure (SBP) at Week 12
An ANCOVA model is used for analysis.
Time frame: Baseline to Week 12
Percentage of Participants With Hemoglobin A1c (HbA1c) <7.0% at Week 26
Time frame: Week 26
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Investigational Site Number 8409009
Escondido, California, United States
Investigational Site Number 8409010
Greenbrae, California, United States
Investigational Site Number 8409005
Walnut Creek, California, United States
Investigational Site Number 8409012
Columbus, Georgia, United States
Investigational Site Number 8409011
Evansville, Indiana, United States
Investigational Site Number 8409014
Wichita, Kansas, United States
Investigational Site Number 8409015
Albuquerque, New Mexico, United States
Investigational Site Number 8409002
Chapel Hill, North Carolina, United States
Investigational Site Number 8409001
Wilmington, North Carolina, United States
Investigational Site Number 8409008
Dayton, Ohio, United States
...and 43 more locations
Percentage of Participants With Adverse Events (AEs)
An AE is any untoward medical occurrence in a participant or clinical investigation participant administered a pharmaceutical product and that does not necessarily have a causal relationship with this treatment.
Time frame: up to 106 weeks