Status:
COMPLETED
Efficacy and Safety Study of MP-513 in Patients With Type 2 Diabetes
Lead Sponsor:
Tanabe Pharma Corporation
Conditions:
Type 2 Diabetes
Eligibility:
All Genders
20-75 years
Phase:
PHASE2
Brief Summary
The purpose of this study is to evaluate the efficacy and safety and to determine the appropriate dose for phase 3 confirmatory trial, of MP-513 (Teneligliptin) in patients with type 2 Diabetes based ...
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 6.5 - 9.5%
- Patients who were not administered drugs prohibited for concomitant use within 12 weeks before administration of investigational drug.
Exclusion
- Patients with type 1 diabetes, diabetes mellitus caused by pancreas failure, or secondary diabetes (Cushing disease, acromegaly, etc)
- Patients with Class III/IV heart failure symptoms according to New York Heart Association (NYHA) functional classification
- Patients with serious diabetic complications
- Patients who are habitual excessive alcohol consumption.
- Patients with severe hepatic disorder or severe renal disorder.
- Pregnant, lactating, and probably pregnant patients, and patients who can not agree to contraception
Key Trial Info
Start Date :
January 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 1 2009
Estimated Enrollment :
324 Patients enrolled
Trial Details
Trial ID
NCT00628212
Start Date
January 1 2008
End Date
January 1 2009
Last Update
January 2 2026
Active Locations (1)
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1
Takikawa-shi, Hokkaido, Japan