At a glance
ClinicalIndex Comparison RecordPhase 3Completed· 793 enrolled
Drug / intervention
Placebo +1 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.
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
In Brief
A Phase 3 clinical trial evaluating Placebo and Sotagliflozin for Type 1 Diabetes Mellitus. Completed, enrolled 793 participants across 75 sites in 2 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
CountriesCanada, United States
CollaboratorsSanofi
Timeline
Phase 3CompletedFinished
201520162017201820192020202120222023202420252026
Enrollment StartMar 2015
First PostedMar 2015
Primary CompletionSep 2016
Study CompletionFeb 2017
TodayJul 2026
First PostedMar 10, 2015
Enrollment StartMar 1, 2015
Primary CompletionSep 1, 2016
Study CompletionFeb 1, 2017
TodayJul 2, 2026
Enrollment to primary: 1.5 yearsPosted 11.3 years ago
Interventions
Placebodrug
Placebo once daily, before first meal of the day.
Sotagliflozindrug
Sotagliflozin once daily, before first meal of the day.