Conditions: Type 2 Diabetes
Keywords: Type 2 Diabetes Metformin
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 403
Healthy volunteers: no

Brief summary:
The purpose of this study is to assess the safety and effectiveness of KRP-104 on glycemic control in patients with type 2 diabetes inadequately controlled on metformin alone.

Detailed description:

Arms:
arm 1: Tablet, once-daily for 24 weeks arm 2: Tablet, once-daily for 24 weeks arm 3: Tablet, once-daily for 24 weeks arm 4: Tablet, once-daily for 24 weeks (dose switch from 20 to 120 mg at week 12) arm 5: Tablet, once-daily for 24 weeks

Interventions: intervention 1: KRP-104 intervention 2: Placebo
Intervention descriptions: intervention 1: Tablet intervention 2: Tablet

Protocol document: