Primary Objective: To demonstrate the superiority of Sotagliflozin 200 milligrams (mg) and Sotagliflozin 400 mg versus placebo on HbA1c reduction at 26 Weeks in participants with Type 2 diabetes who have inadequate glycemic control and moderate renal impairment. Secondary Objectives: * To assess the effects of Sotagliflozin 200 mg and 400 mg versus placebo with respect to additional measures of glycemic control, blood pressure, and body weight. * To evaluate the safety of Sotagliflozin 200 mg and 400 mg versus placebo.
The study duration is up to 60 weeks including 4 weeks prior to randomization, 52 weeks of randomized treatment, and a visit 4 weeks after completion of the randomized treatment period.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Enrollment
787
Placebo tablet (identical to sotagliflozin 200 mg in appearance), orally once daily. Route of administration: Oral
Sotagliflozin 200 mg, tablet, orally once daily. Route of administration: Oral
Investigational Site Number 8404018
Birmingham, Alabama, United States
Investigational Site Number 8404045
Guntersville, Alabama, United States
Investigational Site Number 8404004
Phoenix, Arizona, United States
Investigational Site Number 8404022
Phoenix, Arizona, United States
Investigational Site Number 8404007
Little Rock, Arkansas, United States
Change From Baseline in HbA1c at Week 26
An Analysis of covariance (ANCOVA) model was used for analysis.
Time frame: Baseline to Week 26
Change From Baseline in Fasting Plasma Glucose (FPG) at Week 26
An ANCOVA model was used for analysis.
Time frame: Baseline to Week 26
Change From Baseline in SBP for Participants With Baseline SBP ≥130 mmHg at Week 12
An ANCOVA model was used for analysis.
Time frame: Baseline to Week 12
Change From Baseline in SBP at Week 12 for All Participants
An ANCOVA model was used for analysis.
Time frame: Baseline to Week 12
Change From Baseline in Body Weight at Week 26
An ANCOVA model was used for analysis.
Time frame: Baseline to Week 26
Percentage Change From Baseline in the Urine Albumin: Creatinine Ratio (UACR) at Week 26 in Participants With Baseline UACR >30 Milligrams Per Gram (mg/g)
An ANCOVA model was used for analysis. No Measure of Dispersion was pre-specified to be calculated.
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
Percentage of Participants With Treatment-emergent Adverse Events (TEAEs)
Time frame: Up to 60 weeks
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Investigational Site Number 8404023
Chula Vista, California, United States
Investigational Site Number 8404044
Gold River, California, United States
Investigational Site Number 8404011
Los Angeles, California, United States
Investigational Site Number 8404003
Norco, California, United States
Investigational Site Number 8404025
Northridge, California, United States
...and 160 more locations