At a glance
ClinicalIndex Comparison RecordPhase 2Completed· 87 enrolled
Drug / intervention
Sotagliflozin +1 moredrug
Likely dose
Sotagliflozin 400 mgfrom 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 2, Multicenter, Randomized, Double-blind, Placebo-controlled, Parallel-group Study to Evaluate the Efficacy and Safety of LX4211 in Young Adult Patients With Type 1 Diabetes Mellitus and Elevated Hemoglobin A1C
In Brief
A Phase 2 clinical trial evaluating Sotagliflozin and Placebo for Type 1 Diabetes Mellitus. Completed, enrolled 87 participants across 15 sites.
Detailed Summary
This Phase 2 study was intended to demonstrate superiority of sotagliflozin versus placebo on Hemoglobin A1C (A1C) reduction at Week 12 in young adult participants with type 1 diabetes mellitus (T1DM) who have poor glycemic control on their current insulin regimen.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsType 1 Diabetes Mellitus
CountriesUnited States
CollaboratorsJuvenile Diabetes Research Foundation, Sanofi
Timeline
Phase 2CompletedFinished
201520162017201820192020202120222023202420252026
First PostedMar 2015
Enrollment StartApr 2015
Primary CompletionSep 2016
TodayJul 2026
First PostedMar 10, 2015
Enrollment StartApr 1, 2015
Primary CompletionSep 1, 2016
TodayJul 2, 2026
Enrollment to primary: 1.4 yearsPosted 11.3 years ago
Interventions
Sotagliflozindrug
Sotagliflozin 400 mg, once daily before the first meal of the day
Placebodrug
Placebo, once daily before the first meal of the day