Conditions: Type 1 Diabetes Mellitus
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 36
Healthy volunteers: no

Brief summary:
This Phase 2 study was intended to assess the pharmacodynamics (PD), pharmacokinetics (PK), safety and efficacy of sotagliflozin following daily oral administration for 29 days in participants with type 1 diabetes mellitus (T1DM).

Detailed description:

Arms:
arm 1: Sotagliflozin 400 milligram (mg) (two 200 mg tablets), once daily, orally, before breakfast for 29 days; open label administration. arm 2: Two placebo-matching sotagliflozin tablets, once daily, orally, before breakfast for 29 days; double-blind administration. arm 3: Sotagliflozin 400 mg (two 200 mg tablets), once daily, orally, before breakfast for 29 days; double-blind administration.

Interventions: intervention 1: Sotagliflozin intervention 2: Placebo intervention 3: Sotagliflozin
Intervention descriptions: intervention 1: Participants received sotagliflozin once daily for 29 days. Pioneer Group participants were to have completed dosing prior to any study drug administration in Expansion Groups. intervention 2: Participants received placebo-matching sotagliflozin tablets once daily for 29 days. intervention 3: Participants received sotagliflozin once daily for 29 days; pioneer participants completed dosing prior to dosing any other study participants.

Protocol document: