Efficacy and Safety Study of Teneligliptin (MP-513) in Combination With Insulin in Patients With Type 2 Diabetes

A Phase IV Study of Teneligliptin (MP-513) in Combination With Insulin in Japanese Patients With Type 2 Diabetes Mellitus

The purpose of this study is to evaluate the efficacy and safety of Teneligliptin in combination with Insulin in patients with type 2 Diabetes for 16 weeks administration and to evaluate the safety and efficacy of Teneligliptin in combination with Insulin with an extension treatment for up to 52 weeks.

Inclusion Criteria:

• Patients who has been receiving a stable dose and regimen of insulin over 12 weeks before administration of investigational drug
• 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 7.5% and 10.5%
• 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 who are accepting treatments of arrhythmias
• 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