NCT03351478

Efficacy and Safety of Sotagliflozin Versus Placebo and Empagliflozin in Participants With Type 2 Diabetes Mellitus Who Have Inadequate Glycemic Control While Taking a DPP4 Inhibitor Alone or With Metformin

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

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 770 (actual)
• Sponsor: Lexicon Pharmaceuticals · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Type 2 Diabetes Mellitus

Interventions

Type	Name	Description
DRUG	Sotagliflozin	Sotagliflozin 400 mg was administered as two tablets, once daily before the first meal of the day.
DRUG	Empagliflozin	Empagliflozin 25 mg capsule was administered, once daily before the first meal of the day.
DRUG	Placebo	Placebo was administered as two tablets (identical to sotagliflozin in appearance), once daily before the first meal of the day.
DRUG	Placebo	Placebo was administered as one capsule (identical to the empagliflozin capsule in appearance), once daily before the first meal of the day.

Timeline

• Start date: 2017-11-27
• Primary completion: 2019-05-16
• Completion: 2019-05-16
• First posted: 2017-11-22
• Last updated: 2021-05-11
• Results posted: 2021-05-11

Locations

160 sites across 12 countries: United States, Bulgaria, Canada, Czechia, France, Italy, Latvia, Mexico, Russia, Slovakia, Spain, United Kingdom

Regulatory

• FDA-regulated drug study