Efficacy, Safety, and Tolerability Study of Sotagliflozin as Adjunct Therapy in Adult Patients With Type 1 Diabetes Mellitus Who Have Inadequate Glycemic Control With Insulin Therapy (inTandem2)

This Phase 3 study is 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 patients with type 1 diabetes mellitus (T1D) who have inadequate glycemic control with insulin therapy.


Study Type: Interventional  (Clinical Trial)
Actual Enrollment: 782 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 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
Study Start Date: May 2015
Actual Primary Completion Date: November 2016
Actual Study Completion Date: July 2017

Arms:
- Experimental: Treatment A
High dose Sotagliflozin (fasted conditions)
- Experimental: Treatment B
Low dose Sotagliflozin (fasted conditions)
- Placebo Comparator: Treatment C
Placebo (fasted conditions)