CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 782 enrolled
Drug / intervention
Sotagliflozin +2 moredrug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT02421510
NCT02421510Phase 3Completed
CompareCT.gov

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

Lexicon Pharmaceuticals·interventional·Posted Apr 20, 2015·Updated Feb 12, 2020

In Brief

A Phase 3 clinical trial evaluating Sotagliflozin and Placebo for Type 1 Diabetes Mellitus. Completed, enrolled 782 participants across 96 sites in 17 countries.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsType 1 Diabetes Mellitus
CountriesAustria, Belgium, Bulgaria, France, Germany, Hungary, Israel, Italy, Lithuania, Netherlands, Poland, Romania, Slovakia, Spain, Sweden, Switzerland, United Kingdom
CollaboratorsSanofi

Timeline

Phase 3CompletedFinished
201520162017201820192020202120222023202420252026
First PostedApr 20, 2015
Enrollment StartMay 1, 2015
Primary CompletionNov 1, 2016
Study CompletionJun 23, 2017
TodayJul 2, 2026
Enrollment to primary: 1.5 yearsPosted 11.2 years ago

Interventions

Sotagliflozindrug

High dose Sotagliflozin, once daily, before the first meal of the day

Sotagliflozindrug

Low dose Sotagliflozin,once daily, before the first meal of the day

Placebodrug

Placebo, once daily, before the first meal of the day