Long-term Safety Study of MP-513 in Patients With Type 2 Diabetes

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 oral antihyperglycaemic agent in 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 Oral Antihyperglycaemic Agent 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: glinide
* Drug: biguanide
* Drug: alpha-glucosidase inhibitor


Participation Criteria
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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

Ages Eligible for Study
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Minimum Age: 20 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 (20 mg once daily, titrated to 40 mg if no adequate efficacy is obtained ) | Drug: teneligliptin<br> <br> * Other names: MP-513;|
| Experimental: teneligliptin and glinide<br>teneligliptin (20 mg once daily, titrated to 40 mg if no adequate efficacy is obtained ) plus glinide | Drug: teneligliptin<br> <br> * Other names: MP-513;Drug: glinide<br> <br> |
| Experimental: teneligliptin and biguanide<br>teneligliptin (20 mg once daily, titrated to 40 mg if no adequate efficacy is obtained ) plus biguanide | Drug: teneligliptin<br> <br> * Other names: MP-513;Drug: biguanide<br> <br> |
| Experimental: teneligliptin and alpha-glucosidase inhibitor<br>teneligliptin (20 mg once daily, titrated to 40 mg if no adequate efficacy is obtained ) plus alpha-glucosidase inhibitor | Drug: teneligliptin<br> <br> * Other names: MP-513;Drug: alpha-glucosidase inhibitor<br> <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 52 weeks | 
| Change From Baseline in Fasting Plasma Glucose at Week 52 |  | Baseline and 52 weeks | 
| Change From Baseline in Fasting Glucagon at Week 52 |  | Baseline and 52 weeks | 
| Change From Baseline in Fasting Immuno Reactive Insulin (IRI) at Week 52 |  | Baseline and 52 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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insulin resistance