Monotherapy Study of MP-513 in Patients With Type 2 Diabetes

A Phase III, Double-blind, Placebo Controlled, Monotherapy Study of MP-513 in Japanese Patients With Type 2 Diabetes Mellitus - Confirmative Study

The purpose of this study is to evaluate the efficacy and safety of MP-513 (Teneligliptin) in patients with type 2 Diabetes for 12 weeks administration.

Inclusion Criteria:

• 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 6.5% - 10.0%
• Patients who were not administered diabetes therapeutic drugs within 12 weeks before administration of investigational drug.

Exclusion Criteria:

• 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 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.
• Patients who are pregnant, lactating, and probably pregnant patients, and patients who can not agree to contraception