At a glance
ClinicalIndex Comparison RecordPhase 2Completed· 141 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 2b, Dose-ranging, Randomized, Double-blind, Placebo-controlled, Parallel-group, Multicenter Study in Patients With Type 1 Diabetes Mellitus Who Have Inadequate Glycemic Control With Insulin Therapy
In Brief
A Phase 2 clinical trial evaluating Placebo and Sotagliflozin for Type 1 Diabetes Mellitus. Completed, enrolled 141 participants across 17 sites.
Detailed Summary
The primary objective of this study was to define the dose leading to desirable efficacy, as measured by the change in hemoglobin A1C (A1C) between Baseline and Week 12.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsType 1 Diabetes Mellitus
CountriesUnited States
CollaboratorsSanofi
Timeline
Phase 2CompletedFinished
20162017201820192020202120222023202420252026
First PostedJun 2015
Enrollment StartJul 2015
Primary CompletionAug 2016
TodayJul 2026
First PostedJun 2, 2015
Enrollment StartJul 1, 2015
Primary CompletionAug 1, 2016
TodayJul 2, 2026
Enrollment to primary: 1.1 yearsPosted 11.1 years ago
Interventions
Placebodrug
Placebo, once daily, before the first meal of the day
Sotagliflozindrug
Sotagliflozin,once daily, before the first meal of the day