A Phase 3 Study to Evaluate the Safety of Sotagliflozin in Patients With Type 1 Diabetes Who Have Inadequate Glycemic Control With Insulin Therapy Alone (inTandem3)

This Phase 3 study is designed to demonstrate the net benefit of sotagliflozin versus placebo in patients with T1D.


Study Type: Interventional  (Clinical Trial)
Actual Enrollment: 1405 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: 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
Study Start Date: September 2015
Actual Primary Completion Date: April 2017
Actual Study Completion Date: April 2017

Arms:
- Experimental: Treatment A
Sotagliflozin (fasted conditions)
- Placebo Comparator: Treatment B
Placebo (fasted conditions)