Long-Term Safety Study of Canagliflozin (TA-7284) in Combination With GLP-1 Analogue in Patients With Type 2 Diabetes Mellitus

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 Canagliflozin (TA-7284) in combination with GLP-1 analogue in patients with type 2 Diabetes for 52 weeks.

Detailed Description
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This is an open-label study to evaluate the long-term safety and efficacy of Canagliflozin (TA-7284) in Japanese patients with type 2 diabetes mellitus, who are receiving treatment with GLP-1 analogue on diet and exercise and have inadequate glycemic control. The patients will receive TA-7284 100mg orally for 52 weeks.

Official Title
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An Open-Label, Multicenter Study to Evaluate the Long-Term Safety, Tolerability and Efficacy of Canagliflozin (TA-7284) as add-on to GLP-1 Analogue in Subjects With Type 2 Diabetes Mellitus

Conditions
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Type 2 Diabetes Mellitus

Intervention / Treatment
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* Drug: Canagliflozin (TA-7284)
* Drug: GLP-1 analogue


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 GLP-1 analogue over 12 weeks before administration of investigational dug Patients who are under dietary management and taking therapeutic exercise for diabetes over 12 weeks before administration of investigational drug Patients with HbA1c of ≥7.0% and <10.5% 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 mellitus, diabetes mellitus resulting from pancreatic disorder, or secondary diabetes mellitus (Cushing's syndrome, acromegaly, etc.) Patients with severe diabetic complications (proliferative diabetic retinopathy, stage 4 nephropathy, or serious diabetic neuropathy) Patients with hereditary glucose-galactose malabsorption or primary renal glucosuria Patients with systolic blood pressure of ≥160 mmHg or diastolic blood pressure of ≥100 mmHg Patients with serious renal or hepatic disease Patients with eGFR of <45 mL/min/1.73 m2 Patients who are the excessive alcohol addicts Patients requiring insulin therapy 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
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Canagliflozin (TA-7284) ＋GLP-1 analogue<br> | Drug: Canagliflozin (TA-7284)<br>* The patients will receive Canagliflozin orally for 52 weeks<br>Drug: GLP-1 analogue<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Safety and Tolerability Assessed by Adverse Events (Number of Participants Experiencing With Adverse Events) |  | 52 Weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Percentage of HbA1c |  | Baseline, 52 Weeks | 
| Change in Fasting Plasma Glucose |  | Baseline, 52 Weeks | 
| Percentage Change in Body Weight |  | Baseline, 52 Weeks | 
| Change in Blood Pressure |  | Baseline, 52 Weeks | 

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