Monotherapy Study of MP-513 in Patients With Type 2 Diabetes

Tanabe Pharma Corporation

Status and phase

Completed

Phase 3

Conditions

Type 2 Diabetes Mellitus

Treatments

Drug: Placebo

Drug: Teneligliptin 20 mg

Study type

Interventional

Funder types

Industry

Identifiers

NCT00998881

3000-A5

Details and patient eligibility

About

The purpose of this study is to evaluate the efficacy and safety of MP-513 (Teneligliptin) in patients with type 2 Diabetes for 12 weeks administration.

Enrollment

203 patients

Sex

All

Ages

20 to 75 years old

Volunteers

No Healthy Volunteers

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 6.5% - 10.0%
Patients who were not administered diabetes therapeutic drugs 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 New York Heart Association (NYHA) functional classification
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