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

• Status: Completed
• Trial end date: 2011-04-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Mitsubishi Tanabe Pharma Corporation
• Treatments: Metformin

Criteria

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.