Efficacy and 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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The purpose of this study is to evaluate the efficacy and safety of Canagliflozin (TA-7284) in combination with Insulin in patients with type 2 Diabetes for 16 weeks administration.

Detailed Description
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This is a randomized, 2-arm, parallel group, double blind study to evaluate the efficacy and safety of Canagliflozin (TA-7284) in Japanese patients with type 2 diabetes mellitus, who are receiving treatment with insulin therapy on diet and exercise and have inadequate glycemic control. The patients will receive either TA-7284 100mg or Placebo orally for 16 weeks.

Official Title
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A Randomized, Double-Blind, Placebo-Controlled, Parallel-Group, Multicenter Study to Evaluate the Efficacy, Safety, and Tolerability 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: Placebo
* Drug: Insulin


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 insulin 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 ≥7.5% 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 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
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


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 16 weeks<br>Drug: Insulin<br> <br> |
| Placebo Comparator: Placebo＋insulin<br> | Drug: Placebo<br>* The patients will receive Placebo orally for 16 weeks<br>Drug: Insulin<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in HbA1c From Baseline |  | baseline and Week 16 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Fasting Plasma Glucose |  | baseline and Week 16 | 
| Percent Change in Body Weight |  | baseline and Week 16 | 
| Change in Blood Pressure |  | baseline and Week 16 | 
| Percentage of Participants With Adverse Events and Hypoglycemia and Blood Glucose Decreased |  | Week 16 | 

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