Confirmatory Study of MT-2412 in Japanese Patients With Type 2 Diabetes (Add-on Study of Teneligliptin)

Study Overview
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Brief Summary
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The purpose of this study is to evaluate the efficacy and safety of co-administration of Canagliflozin (TA-7284) and Teneligliptin (MP-513) once daily for 24 weeks in Japanese patients with Type 2 diabetes mellitus who are receiving treatment with Canagliflozin and have inadequate glycemic control.

Official Title
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Confirmatory Study of MT-2412 in Japanese Patients With Type 2 Diabetes (Add-on Study of Teneligliptin in Patients With Inadequate Glycemic Control on Canagliflozin)

Conditions
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Type 2 Diabetes Mellitus

Intervention / Treatment
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* Drug: Canagliflozin
* Drug: Teneligliptin
* Drug: Placebo


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Men or women who are 20 - 75 years old HbA1c of ≥7.0% and <10.5% FPG of ≤ 270 mg/dL Patients who are under dietary management and taking therapeutic exercise for diabetes over 8 weeks before run-in period Exclusion Criteria: Patients with type I diabetes, diabetes mellitus resulting from pancreatic disorder, or secondary diabetes Patients with serious diabetic complications Patients with hereditary glucose-galactose malabsorption or primary renal glucosuria Patients with Class III/IV heart failure symptoms according to New York Heart Association (NYHA) functional classification Patients with severe hepatic disorder or severe renal disorder.

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: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Teneligliptin + Canagliflozin<br>Patients receive Teneligliptin for 24 weeks in combination with Canagliflozin. | Drug: Canagliflozin<br> <br> * Other names: Canaglu, TA-7284;Drug: Teneligliptin<br> <br> * Other names: Tenelia, MP-513;|
| Placebo Comparator: Placebo + Canagliflozin<br>Patients receive placebo for 24 weeks in combination with Canagliflozin. | Drug: Canagliflozin<br> <br> * Other names: Canaglu, TA-7284;Drug: Placebo<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change From Baseline in Percentage of Glycated Hemoglobin (HbA1c) | The change from baseline in percentage of HbA1c (the concentration of glucose bound to hemoglobin as a percent of the absolute maximum that can be bound) collected at Week 24. | Baseline, 24 Weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change From Baseline in Fasting Plasma Glucose Level | The change from baseline in fasting plasma glucose level collected at Week 24. | Baseline, 24 Weeks | 
| Percentage Change in Body Weight From Baseline | The percentage change from baseline in body weight collected at Week 24. | Baseline, 24 Weeks | 
| Change From Baseline in the AUC(0-2h) for Postprandial Plasma Glucose (PPG) | The change from Baseline in AUC(0-2h) for Postprandial Plasma Glucose collected at Week 24. | 0, 0.5, 1 and 2 hour postprandial, at Baseline and 24 Weeks | 
| Change From Baseline in 2-hour Postprandial Plasma Glucose Level | The change from baseline in 2-hour postprandial plasma glucose level collected at Week 24. | 2 Hours Postprandial, at Baseline and 24 Weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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MT-2412, MP-513, TA-7284, Teneligliptin, Canagliflozin