Conditions: Type 2 Diabetes Mellitus
Keywords: Insulin resistance
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 448
Healthy volunteers: no

Brief summary:
The purpose of this study is to evaluate the safety and efficacy of MP-513 in combination with Metformin in patients with type 2 diabetes for 24 weeks administration and to evaluate the safety and efficacy of MP-513 in combination with Metformin with an extension treatment for up to 52 weeks.

Detailed description:

Arms:
arm 1: None arm 2: None arm 3: None arm 4: None arm 5: None

Interventions: intervention 1: MP-513 Lowest Dose and Metformin intervention 2: MP-513 Low Dose and Metformin intervention 3: MP-513 Medium Dose and Metformin intervention 4: MP-513 High Dose and Metformin intervention 5: Placebo and Metformin
Intervention descriptions: intervention 1: MP-513 tablets, once a day and Metformin tablets, for 24 weeks and extension treatment for up to 52 weeks. intervention 2: MP-513 tablets, once a day and Metformin tablets, for 24 weeks and extension treatment for up to 52 weeks. intervention 3: MP-513 tablets, once a day and Metformin tablets, for 24 weeks and extension treatment for up to 52 weeks. intervention 4: MP-513 tablets, once a day and Metformin tablets, for 24 weeks and extension treatment for up to 52 weeks. intervention 5: Placebo tablets once a day, and Metformin tablets, for 24 weeks and extension treatment for up to 52 weeks.

Protocol document: