Efficacy and Safety Study of MP-513 in Patients With Type 2 Diabetes

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to evaluate the efficacy and safety and to determine the appropriate dose for phase 3 confirmatory trial, of MP-513 (Teneligliptin) in patients with type 2 Diabetes based on the change of HbA1c and adverse events after 12 weeks administration once daily in multi-center, randomized, double-blind, placebo-controlled, parallel assignment manner.

Official Title
-----------------
A Phase II, Double-Blind, Placebo-Controlled, Monotherapy Study of MP-513 in Japanese Patients With Type 2 Diabetes Mellitus -Confirmative Study-

Conditions
-----------------
Type 2 Diabetes

Intervention / Treatment
-----------------
* Drug: Teneligliptin 10mg
* Drug: Teneligliptin 20 mg
* Drug: Teneligliptin 40 mg
* Drug: Placebo


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients who are 20 - 75 years old Patients who are under dietary management and taking therapeutic exercise for diabetes over 12 weeks before administration of investigational drug Patients whose HbA1c is 6.5 - 9.5% Patients who were not administered 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 failure, or secondary diabetes (Cushing disease, acromegaly, etc) Patients with Class III/IV heart failure symptoms according to New York Heart Association (NYHA) functional classification Patients with serious diabetic complications Patients who are habitual excessive alcohol consumption. Patients with severe hepatic disorder or severe renal disorder. Pregnant, lactating, and probably pregnant patients, and patients who can not agree to contraception

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

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Teneligliptin 10 mg<br>Teneligliptin 10 mg, orally, once daily | Drug: Teneligliptin 10mg<br> <br> * Other names: MP-513;|
| Experimental: Teneligliptin 20 mg<br>Teneligliptin 20 mg, orally, once daily | Drug: Teneligliptin 20 mg<br> <br> * Other names: MP-513;|
| Experimental: Teneligliptin 40 mg<br>Teneligliptin 40 mg, orally, once daily | Drug: Teneligliptin 40 mg<br> <br> * Other names: MP-513;|
| Placebo Comparator: Placebo<br>Teneligliptin placebo-matching tablets, orally, once daily | Drug: Placebo<br> <br> |

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change From Baseline in HbA1c at Week 12 | The change from Baseline in HbA1c (the concentration of glucose bound to hemoglobin as a percent of the absolute maximum that can be bound) collected at Week 12. Least squares means were derived from an analysis of covariance (ANCOVA) model with treatment as a fixed effect and baseline HbA1c as a covariate. | 12 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change From Baseline in Fasting Plasma Glucose at Week 12 | The change from Baseline in Fasting Plasma Glucose collected at Week 12. Least squares means were derived from an analysis of covariance (ANCOVA) model with treatment as a fixed effect and baseline Fasting Plasma Glucose as a covariate. | 12 weeks | 
| Change From Baseline in 2-hour Postprandial Plasma Glucose at Week 12 | The change from Baseline in 2-hour Postprandial Plasma Glucose collected at Week 12. Least squares means were derived from an analysis of covariance (ANCOVA) model with treatment as a fixed effect and baseline 2-hour Postprandial Plasma Glucose as a covariate. | 12 weeks | 
| Change From Baseline in the Areas Under the Curve From 0 to 2 h (AUC0-2h) for Postprandial Plasma Glucose at Week 12 | The change from Baseline in AUC0-2h for Postprandial Plasma Glucose collected at Week 12. Least squares means were derived from an analysis of covariance (ANCOVA) model with treatment as a fixed effect and baseline AUC0-2h for Postprandial Plasma Glucose as a covariate. | 12 weeks | 

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