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

Tanabe Pharma Corporation

Status and phase: Completed; Phase 2

Conditions: Type 2 Diabetes

Treatments: Drug: Teneligliptin 40 mg; Drug: Teneligliptin 20 mg; Drug: Teneligliptin 10mg; Drug: Placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT00628212

3000-A4

Details and patient eligibility

About

The purpose of this study is to evaluate the efficacy and safety and to determine the appropriate dose for phase 3 confirmatory trial, of MP-513 (Teneligliptin) in patients with type 2 Diabetes based on the change of HbA1c and adverse events after 12 weeks administration once daily in multi-center, randomized, double-blind, placebo-controlled, parallel assignment manner.

Enrollment: 324 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 6.5 - 9.5%
• Patients who were not administered 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 failure, 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.
• Pregnant, lactating, and probably pregnant patients, and patients who can not agree to contraception

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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324 participants in 4 patient groups, including a placebo group

Teneligliptin 10 mg

Experimental group

Description:

Teneligliptin 10 mg, orally, once daily

Treatment:

Drug: Teneligliptin 10mg

Teneligliptin 20 mg

Experimental group

Description:

Teneligliptin 20 mg, orally, once daily

Treatment:

Drug: Teneligliptin 20 mg

Teneligliptin 40 mg

Experimental group

Description:

Teneligliptin 40 mg, orally, once daily

Treatment:

Drug: Teneligliptin 40 mg

Placebo

Placebo Comparator group

Description:

Teneligliptin placebo-matching tablets, orally, once daily

Treatment:

Drug: Placebo