Overview

Pharmacokinetic/Pharmacodynamic Study of MP-513 With Type 2 Diabetes Mellitus

Status:
Completed
Trial end date:
2010-08-01
Target enrollment:
0
Participant gender:
All
Summary
The purpose of this study is to evaluate the effect of MP-513 on 24-h glycemic control in patients with type 2 Diabetes for 4 weeks administration.
Phase:
Phase 3
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
Mitsubishi Tanabe Pharma Corporation
Criteria
Inclusion Criteria:

- Patients who are 20 - 75 years old

- Patients who are under dietary management and taking therapeutic exercise for diabetes
over 8 weeks before administration of investigational drug

- Patients whose HbA1c is ≥6.5% and <10.0%

- Patients who were not administered diabetes therapeutic drugs prohibited for
concomitant use within 8 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