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

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

139 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-12-31

Study Completion Date

2016-04-30

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)

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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.

Conditions

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Type 2 Diabetes Mellitus

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Canagliflozin (TA-7284) ＋insulin

Group Type EXPERIMENTAL

Canagliflozin (TA-7284)

Intervention Type DRUG

The patients will receive Canagliflozin orally for 36 weeks

Insulin

Intervention Type DRUG

Interventions

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Canagliflozin (TA-7284)

The patients will receive Canagliflozin orally for 36 weeks

Intervention Type DRUG

Insulin

Intervention Type DRUG

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

Minimum Eligible Age

20 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No