Efficacy and Safety of MP-513 in Combination With Metformin in Patients With Type 2 Diabetes

A Phase IIb, Double-blind, Parallel Group, Multi-center, Dose-finding Study to Investigate the Efficacy and Safety of 4 Doses of MP-513 When Added to Ongoing Metformin Monotherapy in Subjects With Type 2 Diabetes Mellitus, With an Open Label Extension

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.

Inclusion Criteria:

• Patients who are aged ≧ 18 years old.
• Patients whose HbA1c is ≧ 7.0 % and < 10.0%.
• Patients whose BMI is ≧ 20.0 and ≦40.0 ㎏/㎡.
• Patients who took metformin monotherapy for at least 56 consecutive days at the screening visit.

Exclusion Criteria:

• Patients with type 1 diabetes or secondary form of diabetes.
• Patients with heart failure symptoms.
• Patients with serious diabetic complications.
• Patients with severe hepatic disorder or severe renal disorder.
• Patients who are the excessive alcohol addicts.
• Patients who are pregnant, lactating and probably pregnant patients and patients who can not agree to contraception.