Long-term Safety Study of MP-513 in Patients With Type 2 Diabetes

• Status: Completed
• Trial end date: 2012-09-01
• Target enrollment: 0
• Participant gender: All

Summary

The purpose of this study is to evaluate the safety and efficacy of MP-513 (Teneligliptin) as monotherapy or in combination with oral antihyperglycaemic agent in patients with type 2 Diabetes for 52 weeks administration.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Mitsubishi Tanabe Pharma Corporation
• Treatments: Biguanides; Glycoside Hydrolase Inhibitors

Criteria

Inclusion Criteria:

• Patients who has been receiving a stable dose and regimen of oral antihyperglycaemic agent (biguanide agent,α-glucosidase inhibitor,rapid insulin secretagogue) for diabetes 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 6.5% - 10.0%

• 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 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