Conditions: Type 1 Diabetes Mellitus
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 141
Healthy volunteers: no

Brief 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.

Detailed description:

Arms:
arm 1: Two placebo-matching sotagliflozin tablets, once daily, orally for 12 weeks. arm 2: Sotagliflozin 75 mg (one 75 mg tablet and one placebo tablet), once daily, orally for 12 weeks. arm 3: Sotagliflozin 200 mg (one 200 mg tablet and one placebo tablet), once daily, orally for 12 weeks. arm 4: Sotagliflozin 400 mg (two 200 mg tablets), once daily, orally for 12 weeks.

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

Protocol document: