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

Study Overview
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Brief Summary
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This extension study was designed to evaluate the safety and efficacy of Canagliflozin (TA-7284) in combination with Insulin in patients with type 2 Diabetes Mellitus. The extension study was an extension to double-blind study of 16 weeks (TA-7284-11)

Detailed Description
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This is an open-label extension study to evaluate the safety and efficacy of Canagliflozin (TA-7284) in combination with insulin in Japanese patients with Type 2 diabetes mellitus, who are not optimally controlled on diet and exercise. The patients will enroll from the double-blind study of 16 weeks and receive TA-7284 100mg orally for 36 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 Insulin 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: Insulin


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients should complete the week 16 assessments in the double-blind study (TA-7284-11) Exclusion Criteria: Patients with hereditary glucose-galactose malabsorption or primary renal glucosuria Patients with severe diabetic complications (proliferative diabetic retinopathy, stage 4 nephropathy, or serious diabetic neuropathy) Patients with serious renal or hepatic disease 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: 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) ＋insulin<br> | Drug: Canagliflozin (TA-7284)<br>* The patients will receive Canagliflozin orally for 36 weeks<br>Drug: Insulin<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) |  | Placebo/CANA: 36 Weeks, CANA/CANA: 52 Weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Percentage of HbA1c |  | Placebo/CANA: Baseline, 36 Weeks; CANA/CANA: Baseline, 52 Weeks | 
| Change in Fasting Plasma Glucose |  | Placebo/CANA: Baseline, 36 Weeks; CANA/CANA: Baseline, 52 Weeks | 
| Percentage Change in Body Weight |  | Placebo/CANA: Baseline, 36 Weeks; CANA/CANA: Baseline, 52 Weeks | 

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