At a glance
ClinicalIndex Comparison Record- ✓Type 2 Diabetes (drug-naïve or on antidiabetic therapy)
- ✓Moderate renal impairment with eGFR ≥30 and <60 mL/min/1.73m² (CKD Stage 3A, 3B)
- ✓HbA1c between 7.0% and 11.0%
- ✕Type 1 diabetes
- ✕Prior SGLT2 inhibitor use (Canagliflozin, Dapagliflozin, Empagliflozin) within 12 months
- ✕Uncontrolled high blood pressure
- ✕Severe anemia, severe cardiovascular disease (including NYHA IV congestive heart failure), respiratory, hepatic, neurological, psychiatric disease, or active malignancy
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
A Randomized, Double-blind, Placebo-controlled, 3-arm, Parallel-group 52-week Multicenter Study to Evaluate the Efficacy and Safety of Sotagliflozin in Patients With Type 2 Diabetes Mellitus and Moderate Renal Impairment Who Have Inadequate Glycemic Control
In Brief
A Phase 3 clinical trial evaluating Placebo and Sotagliflozin for Type 2 Diabetes Mellitus and Chronic Kidney Disease Stage 3. Completed, enrolled 787 participants across 170 sites in 16 countries.
Detailed Summary
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.
Study Details
Timeline
Interventions
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