Primary Objective: To demonstrate the non-inferiority of Sotagliflozin 400 milligrams (mg) compared to Glimepiride on hemoglobin A1c (HbA1c) reduction at Week 52 in participants with Type 2 Diabetes (T2D) who have inadequate glycemic control with metformin. Secondary Objectives: To demonstrate the superiority of Sotagliflozin 400 mg compared to Glimepiride on change in body weight, systolic blood pressure (SBP) in participants with baseline SBP ≥130 millimeter of mercury (mmHg), SBP in all participants, and proportion of participants with at least 1 documented symptomatic hypoglycemic event (≤70 milligrams per deciliter \[mg/dL\]). * To demonstrate the superiority of Sotagliflozin 400 mg compared to placebo on change in HbA1c, body weight, SBP in participants with baseline SBP ≥130 mmHg, SBP in all participants. * To demonstrate the superiority of Sotagliflozin 200 mg compared to placebo on change in HbA1c. * To demonstrate the non-inferiority of Sotagliflozin 400 mg compared to Glimepiride on change in HbA1c. * To demonstrate the superiority of Sotagliflozin 400 mg compared to Glimepiride on change in HbA1c. * To evaluate the safety and tolerability of Sotagliflozin compared to Glimepiride and placebo.
Up to 58 weeks, including a Screening Period consisting of a Screening phase of up to 2 weeks, a 2-week single-blind placebo Run-in phase, a 52-week double-blind Treatment Period, and a 2-week post-treatment Follow-up period to collect safety information.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
954
Pharmaceutical form: tablet Route of administration: oral
Pharmaceutical form: capsule Route of administration: oral
Pharmaceutical form: tablet Route of administration: oral
Pharmaceutical form: tablet Route of administration: oral
Pharmaceutical form: capsule Route of administration: oral
Investigational Site Number 8407040
Birmingham, Alabama, United States
Investigational Site Number 8407048
Birmingham, Alabama, United States
Investigational Site Number 8407035
Little Rock, Arkansas, United States
Investigational Site Number 8407051
Anaheim, California, United States
Investigational Site Number 8407065
Canoga Park, California, United States
Change From Baseline in Hemoglobin A1c at Week 52
An analysis of covariance (ANCOVA) model was used for the analysis.
Time frame: Baseline, Week 52
Change From Baseline in Hemoglobin A1c 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 and 52
An ANCOVA model was used for the analysis.
Time frame: Baseline, Week 26, Week 52
Change From Baseline in Systolic Blood Pressure (SBP) for Participants With SBP ≥130 mmHg at Week 12
An ANCOVA model was used for the analysis.
Time frame: Baseline, Week 12
Change From Baseline in Systolic Blood Pressure (SBP) for All Participants at Week 12
An ANCOVA model was used for the analysis.
Time frame: Baseline, Week 12
Percentage of Participants With At Least One Documented Symptomatic Hypoglycemic Event
Documented symptomatic hypoglycemia includes the typical symptoms of hypoglycemia (increased sweating, nervousness, asthenia/weakness, tremor, dizziness, increased appetite, palpitations, headache, sleep disorder, confusion, seizures, unconsciousness, and/or coma) and plasma glucose ≤ 70 mg/dL (3.9 mmol/L).
Time frame: Up to Week 52
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 Week 52
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Investigational Site Number 8407078
Carmichael, California, United States
Investigational Site Number 8407089
Downey, California, United States
Investigational Site Number 8407011
Gold River, California, United States
Investigational Site Number 8407044
Greenbrae, California, United States
Investigational Site Number 8407006
Huntington Park, California, United States
...and 132 more locations