Long-Term Safety Study of MT-2412 in Japanese 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 co-administration of Teneligliptin (MP-513) and Canagliflozin (TA-7284) once daily for 52 weeks in Japanese patients with Type 2 diabetes mellitus who are receiving treatment with Teneligliptin and have inadequate glycemic control.

Official Title
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Long-term Administration Study of MT-2412 in Patients With Type 2 Diabetes Mellitus

Conditions
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Type 2 Diabetes Mellitus

Intervention / Treatment
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* Drug: Teneligliptin/Canagliflozin


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Men or women age ≥20 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 12 weeks before treatment 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

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
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Teneligliptin/Canagliflozin<br>Patients receive Teneligliptin and Canagliflozin once daily for 52 weeks. | Drug: Teneligliptin/Canagliflozin<br>* Co-administration of Teneligliptin and Canagliflozin orally once daily for 52 weeks.<br>* Other names: TA-7284;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Participants With Adverse Events |  | 52 Weeks | 

Secondary 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 52. | Baseline, 52 Weeks | 
| Change From Baseline in Fasting Plasma Glucose Level | The change from baseline in fasting plasma glucose level collected at Week 52. | Baseline, 52 Weeks | 
| Percentage Change in Body Weight From Baseline | The percentage change from baseline in body weight collected at Week 52. | Baseline, 52 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