NCT02421510

Efficacy, Safety, and Tolerability Study of Sotagliflozin as Adjunct Therapy in Adult Patients With Type 1 Diabetes Mellitus Who Have Inadequate Glycemic Control With Insulin Therapy

A Phase 3, Randomized, Double-blind, Placebo-controlled, Parallel-group, Multicenter Study to Evaluate the Efficacy, Safety, and Tolerability of LX4211 as Adjunct Therapy in Adult Patients With Type 1 Diabetes Mellitus Who Have Inadequate Glycemic Control With Insulin Therapy

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 782 (actual)
• Sponsor: Lexicon Pharmaceuticals · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This Phase 3 study was intended to demonstrate superiority of either Sotagliflozin high dose or low dose versus placebo on glycosylated hemoglobin A1C (A1C) reduction at Week 24 when used as an adjunct in adult participants with type 1 diabetes mellitus (T1D) who have inadequate glycemic control with insulin therapy.

Conditions

• Type 1 Diabetes Mellitus

Interventions

Type	Name	Description
DRUG	Sotagliflozin	High dose Sotagliflozin, once daily, before the first meal of the day
DRUG	Sotagliflozin	Low dose 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: 2015-05-01
• Primary completion: 2016-11-01
• Completion: 2017-06-23
• First posted: 2015-04-20
• Last updated: 2020-02-12
• Results posted: 2019-10-30

Locations

96 sites across 17 countries: Austria, Belgium, Bulgaria, France, Germany, Hungary, Israel, Italy, Lithuania, Netherlands, Poland, Romania, Slovakia, Spain, Sweden, Switzerland, United Kingdom