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

Mitsubishi Tanabe Pharma

Status and phase: Completed; Phase 4

Conditions: Type 2 Diabetes Mellitus

Treatments: Drug: Canagliflozin (TA-7284); Drug: Insulin

Study type: Interventional

Funder types: Industry

Identifiers

NCT02622113

TA-7284-13

Details and patient eligibility

About

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)

Full description

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.

Enrollment: 139 patients

Sex: All

Ages: 20+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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139 participants in 1 patient group

Canagliflozin (TA-7284) ＋insulin

Experimental group

Treatment:

Drug: Insulin

Drug: Canagliflozin (TA-7284)