Efficacy and Safety Study of MP-513 in Combination With Sulfonylurea in Patients With Type 2 Diabetes

Mitsubishi Tanabe Pharma

Status and phase

Completed

Phase 3

Conditions

Type 2 Diabetes Mellitus

Treatments

Drug: Teneli / Teneli + SU

Drug: Placebo / Teneli (Teneligliptin) + SU (Sulfonylurea)

Study type

Interventional

Funder types

Industry

Identifiers

NCT00974090

3000-A6

Details and patient eligibility

About

The purpose of this study is to evaluate the safety and efficacy of MP-513 (Teneligliptin) in combination with Sulfonylurea in patients with type 2 Diabetes for 12 weeks administration and to evaluate the safety and efficacy of MP-513 in combination with Sulfonylurea with an extension treatment for up to 52 weeks.

Enrollment

194 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 7.0% and 10.0%
Patients who took Sulfonylurea for diabetes over 12 weeks before administration of investigational drug
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 with Class III/IV heart failure symptoms according to NYHA functional classification
Patients who are gastrointestinal disorder (diarrhea, vomiting)
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