Overview
Efficacy and Safety of MP-513 in Combination With Metformin in Patients With Type 2 Diabetes
Status:
Completed
Completed
Trial end date:
2011-04-01
2011-04-01
Target enrollment:
0
0
Participant gender:
All
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 2Accepts Healthy Volunteers?
NoDetails
Lead Sponsor:
Mitsubishi Tanabe Pharma CorporationTreatments:
MetforminCriteria
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.