At a glance
ClinicalIndex Comparison RecordStandardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
A 26-week Randomized, Double-blind, Controlled, Parallel-group, Multicenter Study to Evaluate the Efficacy and Safety of Sotagliflozin Compared to Empagliflozin, and Placebo in Participants With Type 2 Diabetes Who Have Inadequate Glycemic Control on Dipeptidyl Peptidase 4 Inhibitor (DPP4(i)) With or Without Metformin
In Brief
A Phase 3 clinical trial evaluating Sotagliflozin, Empagliflozin, and 1 other intervention for Type 2 Diabetes Mellitus. Completed, enrolled 770 participants across 160 sites in 12 countries.
Detailed Summary
The purpose of the study is to demonstrate the superiority of sotagliflozin versus placebo on hemoglobin A1c (HbA1c) reduction in participants with type 2 diabetes (T2D) who have inadequate glycemic control on a DPP4(i) with or without metformin.
Study Details
Timeline
Interventions
Sotagliflozin 400 mg was administered as two tablets, once daily before the first meal of the day.
Empagliflozin 25 mg capsule was administered, once daily before the first meal of the day.
Placebo was administered as two tablets (identical to sotagliflozin in appearance), once daily before the first meal of the day.
Placebo was administered as one capsule (identical to the empagliflozin capsule in appearance), once daily before the first meal of the day.