Long-term 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

PHASE3

Total Enrollment

462 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-02-28

Study Completion Date

2012-09-30

Brief Summary

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The purpose of this study is to evaluate the safety and efficacy of MP-513 (Teneligliptin) as monotherapy or in combination with oral antihyperglycaemic agent in patients with type 2 Diabetes for 52 weeks administration.

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Detailed Description

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Conditions

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Type 2 Diabetes Mellitus

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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teneligliptin

teneligliptin (20 mg once daily, titrated to 40 mg if no adequate efficacy is obtained )

Group Type EXPERIMENTAL

teneligliptin

Intervention Type DRUG

teneligliptin and glinide

teneligliptin (20 mg once daily, titrated to 40 mg if no adequate efficacy is obtained ) plus glinide

Group Type EXPERIMENTAL

teneligliptin

Intervention Type DRUG

glinide

Intervention Type DRUG

teneligliptin and biguanide

teneligliptin (20 mg once daily, titrated to 40 mg if no adequate efficacy is obtained ) plus biguanide

Group Type EXPERIMENTAL

teneligliptin

Intervention Type DRUG

biguanide

Intervention Type DRUG

teneligliptin and alpha-glucosidase inhibitor

teneligliptin (20 mg once daily, titrated to 40 mg if no adequate efficacy is obtained ) plus alpha-glucosidase inhibitor

Group Type EXPERIMENTAL

teneligliptin

Intervention Type DRUG

alpha-glucosidase inhibitor

Intervention Type DRUG

Interventions

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teneligliptin

Intervention Type DRUG

glinide

Intervention Type DRUG

biguanide

Intervention Type DRUG

alpha-glucosidase inhibitor

Intervention Type DRUG

Other Intervention Names

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MP-513

Eligibility Criteria

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Inclusion Criteria

* Patients who has been receiving a stable dose and regimen of oral antihyperglycaemic agent (biguanide agent,α-glucosidase inhibitor,rapid insulin secretagogue) for diabetes over 12 weeks before administration of investigational drug
* 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 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 who are accepting treatments of arrhythmias
* 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

Minimum Eligible Age

20 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No