Conditions: Type 2 Diabetes Mellitus
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 143
Healthy volunteers: no

Brief summary:
This is a study to assess the safety and efficacy of the addition of ipragliflozin once daily in Japanese participants with Type 2 diabetes mellitus (T2DM) who have inadequate glycemic control on sitagliptin, diet, and exercise therapy. The primary hypothesis for this study is that the addition of ipragliflozin compared with placebo provides greater reduction in hemoglobin A1C (HbA1c) as assessed by change from baseline at Week 24.

Detailed description:

Arms:
arm 1: Ipragliflozin once daily for 24 weeks in addition to sitagliptin, diet, and exercise. arm 2: Placebo to ipragliflozin once daily for 24 weeks in addition to sitagliptin, diet, and exercise.

Interventions: intervention 1: Ipragliflozin intervention 2: Placebo intervention 3: Sitagliptin
Intervention descriptions: intervention 1: 50 mg tablet administered orally intervention 2: Placebo to ipragliflozin tablet administered orally intervention 3: Background medication; 50 mg tablet administered orally

Protocol document: