At a glance
ClinicalIndex Comparison RecordPhase 3Completed· 1,405 enrolled
Drug / intervention
Sotagliflozin +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 Net Clinical Benefit of Sotagliflozin as Adjunct to Insulin Therapy in Type 1 Diabetes
In Brief
A Phase 3 clinical trial evaluating Sotagliflozin and Placebo for Type 1 Diabetes Mellitus (T1DM) and High Level of Sugar (Glucose) in the Blood. Completed, enrolled 1,405 participants across 135 sites in 19 countries.
Detailed Summary
This Phase 3 study was designed to demonstrate the net benefit of sotagliflozin versus placebo in patients with Type 1 Diabetes (T1D).
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesArgentina, Australia, Belgium, Bulgaria, Canada, Colombia, Czechia, France, Germany, Hungary, Israel, Italy, New Zealand, Poland, Slovakia, South Africa, Spain, United Kingdom, United States
CollaboratorsSanofi
Timeline
Phase 3CompletedFinished
20162017201820192020202120222023202420252026
First PostedAug 2015
Enrollment StartSep 2015
Primary CompletionApr 2017
TodayJul 2026
First PostedAug 21, 2015
Enrollment StartSep 1, 2015
Primary CompletionApr 1, 2017
TodayJul 2, 2026
Enrollment to primary: 1.6 yearsPosted 10.9 years ago
Interventions
Sotagliflozindrug
Sotagliflozin, once daily, before the first meal of the day
Placebodrug
Placebo, once daily, before the first meal of the day