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

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

324 participants

Study Classification

INTERVENTIONAL

Study Start Date

2008-01-31

Study Completion Date

2009-01-31

Brief Summary

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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.

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Detailed Description

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Conditions

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Type 2 Diabetes

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Teneligliptin 10 mg

Teneligliptin 10 mg, orally, once daily

Group Type EXPERIMENTAL

Teneligliptin 10mg

Intervention Type DRUG

Teneligliptin 20 mg

Teneligliptin 20 mg, orally, once daily

Group Type EXPERIMENTAL

Teneligliptin 20 mg

Intervention Type DRUG

Teneligliptin 40 mg

Teneligliptin 40 mg, orally, once daily

Group Type EXPERIMENTAL

Teneligliptin 40 mg

Intervention Type DRUG

Placebo

Teneligliptin placebo-matching tablets, orally, once daily

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

Interventions

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Teneligliptin 10mg

Intervention Type DRUG

Teneligliptin 20 mg

Intervention Type DRUG

Teneligliptin 40 mg

Intervention Type DRUG

Placebo

Intervention Type DRUG

Other Intervention Names

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MP-513 MP-513 MP-513

Eligibility Criteria

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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

Minimum Eligible Age

20 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No