Efficacy and Safety of MP-513 in Combination With Metformin 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 in combination with Metformin in patients with type 2 diabetes for 24 weeks administration and to evaluate the safety and efficacy of MP-513 in combination with Metformin with an extension treatment for up to 52 weeks.

Official Title
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A Phase IIb, Double-blind, Parallel Group, Multi-center, Dose-finding Study to Investigate the Efficacy and Safety of 4 Doses of MP-513 When Added to Ongoing Metformin Monotherapy in Subjects With Type 2 Diabetes Mellitus, With an Open Label Extension

Conditions
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Type 2 Diabetes Mellitus

Intervention / Treatment
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* Drug: MP-513 Lowest Dose and Metformin
* Drug: MP-513 Low Dose and Metformin
* Drug: MP-513 Medium Dose and Metformin
* Drug: MP-513 High Dose and Metformin
* Drug: Placebo and Metformin


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients who are aged ≧ 18 years old. Patients whose HbA1c is ≧ 7.0 % and < 10.0%. Patients whose BMI is ≧ 20.0 and ≦40.0 ㎏/㎡. Patients who took metformin monotherapy for at least 56 consecutive days at the screening visit. Exclusion Criteria: Patients with type 1 diabetes or secondary form of diabetes. Patients with heart failure symptoms. Patients with serious diabetic complications. Patients with severe hepatic disorder or severe renal disorder. Patients who are the excessive alcohol addicts. 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: 18 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: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: MP-513 Lowest Dose and Metformin<br> | Drug: MP-513 Lowest Dose and Metformin<br>* MP-513 tablets, once a day and Metformin tablets, for 24 weeks and extension treatment for up to 52 weeks.<br>|
| Experimental: MP-513 Low Dose and Metformin<br> | Drug: MP-513 Low Dose and Metformin<br>* MP-513 tablets, once a day and Metformin tablets, for 24 weeks and extension treatment for up to 52 weeks.<br>|
| Experimental: MP-513 Medium Dose and Metformin<br> | Drug: MP-513 Medium Dose and Metformin<br>* MP-513 tablets, once a day and Metformin tablets, for 24 weeks and extension treatment for up to 52 weeks.<br>|
| Experimental: MP-513 High Dose and Metformin<br> | Drug: MP-513 High Dose and Metformin<br>* MP-513 tablets, once a day and Metformin tablets, for 24 weeks and extension treatment for up to 52 weeks.<br>|
| Placebo Comparator: Placebo and Metformin<br> | Drug: Placebo and Metformin<br>* Placebo tablets once a day, and Metformin tablets, for 24 weeks and extension treatment for up to 52 weeks.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in HbA1c From Baseline to Week 24 | The change of HbA1c from baseline to Week 24 or a last observation carried forward (LOCF), was assessed with an analysis of covariance (ANCOVA) model, with the centre and treatment effect as factors and the baseline HbA1c as a covariate. | Baseline and Week 24 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Fasting Plasma Glucose (FPG) From Baseline to Week 24 | Change in FPG from baseline to Week 24 or LOCF was assessed with an ANCOVA approach similar to that of the primary efficacy endpoint. | Baseline and Week 24 | 
| Adverse Events, Laboratory Tests, Vital Signs, Etc. |  | Weeks 24, 52 | 

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