Conditions: Type 1 Diabetes Mellitus
Keywords: High level of sugar (glucose) in the blood
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 782
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 tablets, once daily, orally, before the first meal of the day for 24 weeks followed by a 28-week extension period. arm 2: Sotagliflozin 200 milligram (mg) (one 200 mg tablet and one placebo tablet), once daily, orally, before the first meal of the day for 24 weeks followed by a 28-week extension period. arm 3: Sotagliflozin 400 mg (two 200 mg tablets), once daily, orally, before the first meal of the day for 24 weeks followed by a 28-week extension period.

Interventions: intervention 1: Sotagliflozin intervention 2: Sotagliflozin intervention 3: Placebo
Intervention descriptions: intervention 1: High dose Sotagliflozin, once daily, before the first meal of the day intervention 2: Low dose Sotagliflozin,once daily, before the first meal of the day intervention 3: Placebo, once daily, before the first meal of the day

Protocol document: