Conditions: Type 1 Diabetes Mellitus
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 793
Healthy volunteers: no

Brief summary:
This Phase 3 study was 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 participants with type 1 diabetes mellitus (T1D) who have inadequate glycemic control with insulin therapy.

Detailed description:

Arms:
arm 1: Two placebo-matching sotagliflozin tables, orally for 24 weeks followed by a 28 week extension period. arm 2: Sotagliflozin 200 mg (one 200 mg tablet and one placebo tablet), orally, for 24 weeks followed by a 28 week extension period. arm 3: Sotagliflozin 400 mg (two 200 mg tablets), orally, for 24 weeks followed by a 28 week extension period.

Interventions: intervention 1: Placebo intervention 2: Sotagliflozin
Intervention descriptions: intervention 1: Placebo once daily, before first meal of the day. intervention 2: Sotagliflozin once daily, before first meal of the day.

Protocol document: