At a glance
ClinicalIndex Comparison RecordStandardized 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 Severe 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 4. Completed, enrolled 277 participants across 106 sites in 15 countries.
Detailed Summary
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
Study Details
Timeline
Interventions
Placebo tablet (identical to sotagliflozin 200 mg in appearance) orally, once daily.
Sotagliflozin 200 mg, tablet, orally, once daily.