Efficacy and Safety Study of MP-513 in Combination With Sulfonylurea in Patients With Type 2 Diabetes

A Phase III Study of MP-513 in Combination With Sulfonylurea in Japanese Patients With Type 2 Diabetes Mellitus

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 the safety and efficacy of MP-513 in combination with Sulfonylurea with an extension treatment for up to 52 weeks.

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 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 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 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