Status:
COMPLETED
Efficacy and Safety of MP-513 in Combination With Metformin in Patients With Type 2 Diabetes
Lead Sponsor:
Tanabe Pharma Corporation
Conditions:
Type 2 Diabetes Mellitus
Eligibility:
All Genders
18+ years
Phase:
PHASE2
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 eff...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
August 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 1 2011
Estimated Enrollment :
448 Patients enrolled
Trial Details
Trial ID
NCT00971243
Start Date
August 1 2009
End Date
April 1 2011
Last Update
January 7 2026
Active Locations (44)
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1
Aalborg, Denmark
2
Ballerup Municipality, Denmark
3
Vejle, Denmark
4
Falkensee, Germany