Status:
COMPLETED
Efficacy and Safety Study of MP-513 in Combination With Sulfonylurea in Patients With Type 2 Diabetes
Lead Sponsor:
Tanabe Pharma Corporation
Conditions:
Type 2 Diabetes Mellitus
Eligibility:
All Genders
20-75 years
Phase:
PHASE3
Brief Summary
The purpose of this study is to evaluate the safety and efficacy of MP-513 (Teneligliptin) in combination with Sulfonylurea in patients with type 2 Diabetes for 12 weeks administration and to evaluate...
Eligibility Criteria
Inclusion
- Patients who are 20 - 75 years old
- Patients who are under dietary management and taking therapeutic exercise for diabetes over 12 weeks before administration of investigational drug
- Patients whose HbA1c is between 7.0% and 10.0%
- Patients who took Sulfonylurea for diabetes over 12 weeks before administration of investigational drug
- Patients who were not administered diabetes therapeutic drugs prohibited for concomitant use within 12 weeks before administration of investigational drug
Exclusion
- Patients with type 1 diabetes, diabetes mellitus caused by pancreas impairment, or secondary diabetes (Cushing disease, acromegaly, etc)
- Patients with Class III/IV heart failure symptoms according to NYHA functional classification
- Patients who are gastrointestinal disorder (diarrhea, vomiting)
- Patients with serious diabetic complications
- Patients who are the excessive alcohol addicts
- Patients with severe hepatic disorder or severe renal disorder
- Patients who are pregnant, lactating, and probably pregnant patients, and patients who can not agree to contraception
Key Trial Info
Start Date :
September 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 1 2011
Estimated Enrollment :
194 Patients enrolled
Trial Details
Trial ID
NCT00974090
Start Date
September 1 2009
End Date
March 1 2011
Last Update
January 5 2026
Active Locations (1)
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1
Sapporo, Hokkaido, Japan