Primary Objective: To demonstrate the superiority of sotagliflozin 400 milligrams (mg) versus placebo with respect to hemoglobin A1c (HbA1c) reduction at Week 26 in participants with Type 2 diabetes who have inadequate glycemic control and severe renal impairment Secondary Objectives: * To assess the effects of sotagliflozin 200 mg versus placebo based on change from baseline in HbA1c * To assess the effects of sotagloflozin 400 mg and 200 mg versus placebo * To evaluate the safety of sotagliflozin 400 mg and 200 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
QUADRUPLE
Enrollment
277
Placebo tablet (identical to sotagliflozin 200 mg in appearance) orally, once daily.
Sotagliflozin 200 mg, tablet, orally, once daily.
Investigational Site Number 8405033
Guntersville, Alabama, United States
Investigational Site Number 8405005
Phoenix, Arizona, United States
Investigational Site Number 8405007
Little Rock, Arkansas, United States
Investigational Site Number 8405015
Chula Vista, California, United States
Investigational Site Number 8405032
La Jolla, California, United States
Change From Baseline in HbA1c at Week 26 Comparing 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 HbA1c at Week 26 Comparing 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
An ANCOVA model was used for the analysis.
Time frame: Baseline to Week 26
Change From Baseline in Body Weight at Week 26
An ANCOVA model was used for the analysis.
Time frame: Baseline to Week 26
Change From Baseline in SBP at Week 12 in Participants With Baseline SBP ≥130 mmHg
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
An ANCOVA model was used for the analysis.
Time frame: Baseline to Week 12
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)
An adverse event (AE) is any untoward medical occurrence in a participants or clinical investigation participants administered a pharmaceutical product and which does not necessarily have to have a causal relationship with the investigational medicinal product (IMP).
Time frame: First dose of study drug to last dose of study drug (up to 56.3 weeks) + 4 weeks
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Investigational Site Number 8405003
Norco, California, United States
Investigational Site Number 8405013
Northridge, California, United States
Investigational Site Number 8405018
San Dimas, California, United States
Investigational Site Number 8405021
Clearwater, Florida, United States
Investigational Site Number 8405001
DeLand, Florida, United States
...and 96 more locations