Overview

Long-term Safety Study of MP-513 as Monotherapy or in Combination With Sulfonylurea in Japanese Type 2 Diabetic Patients

Status:
Completed
Trial end date:
2011-07-01
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 Sulfonylurea (glimepiride) in Japanese patients with type 2 Diabetes for 52 weeks administration.
Phase:
Phase 3
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
Mitsubishi Tanabe Pharma Corporation
Criteria
Inclusion Criteria:

- In case of combination therapy with Sulfonylurea, patients who has been receiving a
stable dose and regimen of sulfonylurea 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

- HbA1c criteria:

- monotherapy: 6.9% - 10.5%

- combination therapy with Sulfonylurea: 7.4 - 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