The purpose of the study is to demonstrate the superiority of sotagliflozin versus placebo on hemoglobin A1c (HbA1c) reduction in participants with type 2 diabetes (T2D) who have inadequate glycemic control on a DPP4(i) with or without metformin.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
770
Sotagliflozin 400 mg was administered as two tablets, once daily before the first meal of the day.
Empagliflozin 25 mg capsule was administered, once daily before the first meal of the day.
Placebo was administered as two tablets (identical to sotagliflozin in appearance), once daily before the first meal of the day.
Change From Baseline in Hemoglobin A1c (HbA1c) % at Week 26
An analysis of covariance (ANCOVA) model was used for the analysis.
Time frame: Baseline, Week 26
Change From Baseline in Sitting Systolic Blood Pressure (SBP) at Week 12 in Participants With Baseline SBP ≥ 130 mmHg
An ANCOVA model was used for the analysis.
Time frame: Baseline, Week 12
Change From Baseline in 2-hour Postprandial Glucose (PPG) Following a Mixed Meal at Week 26
An ANCOVA model was used for the analysis.
Time frame: Baseline, Week 26
Change From Baseline in Fasting Plasma Glucose (FPG) at Week 26
An ANCOVA model was used for the analysis.
Time frame: Baseline, Week 26
Change From Baseline in Body Weight at Week 26
An ANCOVA model was used for the analysis.
Time frame: Baseline, Week 26
Change From Baseline in Sitting SBP at Week 12 for All Participants
An ANCOVA model was used for the analysis.
Time frame: Baseline, Week 12
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
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Placebo was administered as one capsule (identical to the empagliflozin capsule in appearance), once daily before the first meal of the day.
Investigational Site Number 8408035
Birmingham, Alabama, United States
Investigational Site Number 8408028
Sheffield, Alabama, United States
Investigational Site Number 8408047
Hawaiian Gardens, California, United States
Investigational Site Number 8408031
Spring Valley, California, United States
Investigational Site Number 8408067
Van Nuys, California, United States
Investigational Site Number 8408069
Northglenn, Colorado, United States
Investigational Site Number 8408009
Miami, Florida, United States
Investigational Site Number 8408049
Ocoee, Florida, United States
Investigational Site Number 8408005
Orlando, Florida, United States
Investigational Site Number 8408040
Orlando, Florida, United States
...and 150 more locations