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

Study Overview
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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.

Official Title
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Long-term Safety Study of MP-513 as Monotherapy or in Combination With Sulfonylurea in Japanese Patients With Type 2 Diabetes Mellitus

Conditions
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Type 2 Diabetes Mellitus

Intervention / Treatment
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* Drug: Teneligliptin
* Drug: Teneligliptin + Sulfonylurea


Participation Criteria
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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

Ages Eligible for Study
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Minimum Age: 20 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Teneligliptin<br>Teneligliptin for 52 weeks | Drug: Teneligliptin<br>* Teneligliptin for 52 weeks<br>|
| Experimental: Teneligliptin + Sulfonylurea<br>Teneligliptin for 52 weeks in combination with sulfonylurea | Drug: Teneligliptin + Sulfonylurea<br>* Teneligliptin for 52 weeks in combination with sulfonylurea<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Participants With Adverse Events | Treatment-emergent adverse events (TEAE) were defined as any unfavorable and unintended sign, symptom or disease temporally associated with the use of a medicinal product reported from first dose of study drug through 14 days after receiving the last dose of study drug. | 52 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change From Baseline in HbA1c at Week 52 |  | Baseline and Week 52 | 
| Change From Baseline in Fasting Plasma Glucose at Week 52 |  | Baseline and Week 52 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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DPP-IV inhibitor