NCT02531035

A Phase 3 Study to Evaluate the Safety of Sotagliflozin in Patients With Type 1 Diabetes Who Have Inadequate Glycemic Control With Insulin Therapy Alone

A Phase 3, Randomized, Double-blind, Placebo-controlled, Parallel-group, Multicenter Study to Evaluate the Net Clinical Benefit of Sotagliflozin as Adjunct to Insulin Therapy in Type 1 Diabetes

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 1,405 (actual)
• Sponsor: Lexicon Pharmaceuticals · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This Phase 3 study was designed to demonstrate the net benefit of sotagliflozin versus placebo in patients with Type 1 Diabetes (T1D).

Conditions

• Type 1 Diabetes Mellitus (T1DM)
• High Level of Sugar (Glucose) in the Blood

Interventions

Type	Name	Description
DRUG	Sotagliflozin	Sotagliflozin, once daily, before the first meal of the day
DRUG	Placebo	Placebo, once daily, before the first meal of the day

Timeline

• Start date: 2015-09-01
• Primary completion: 2017-04-01
• Completion: 2017-04-01
• First posted: 2015-08-21
• Last updated: 2020-02-12
• Results posted: 2019-11-19

Locations

135 sites across 19 countries: United States, Argentina, Australia, Belgium, Bulgaria, Canada, Colombia, Czechia, France, Germany, Hungary, Israel, Italy, New Zealand, Poland, Slovakia, South Africa, Spain, United Kingdom