Long-term Safety Study of MP-513 as Monotherapy or in Combination With Sulfonylurea in Japanese Type 2 Diabetic Patients

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

240 participants

Study Classification

INTERVENTIONAL

Study Start Date

2009-08-31

Study Completion Date

2011-07-31

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 Sulfonylurea (glimepiride) in Japanese 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 for 52 weeks

Group Type EXPERIMENTAL

Teneligliptin

Intervention Type DRUG

Teneligliptin for 52 weeks

Teneligliptin + Sulfonylurea

Teneligliptin for 52 weeks in combination with sulfonylurea

Group Type EXPERIMENTAL

Teneligliptin + Sulfonylurea

Intervention Type DRUG

Teneligliptin for 52 weeks in combination with sulfonylurea

Interventions

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Teneligliptin

Teneligliptin for 52 weeks

Intervention Type DRUG

Teneligliptin + Sulfonylurea

Teneligliptin for 52 weeks in combination with sulfonylurea

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* In case of combination therapy with Sulfonylurea, patients who has been receiving a stable dose and regimen of sulfonylurea 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
* HbA1c criteria:

* monotherapy: 6.9% - 10.5%
* combination therapy with Sulfonylurea: 7.4 - 10.5%
* 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 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

Minimum Eligible Age

20 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No