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

Tanabe Pharma Corporation

Status and phase: Completed; Phase 4

Conditions: Type 2 Diabetes Mellitus

Treatments: Drug: GLP-1 analogue; Drug: Canagliflozin (TA-7284)

Study type: Interventional

Funder types: Industry

Identifiers

NCT02227849

TA-7284-12

Details and patient eligibility

About

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.

Full description

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.

Enrollment: 71 patients

Sex: All

Ages: 20+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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71 participants in 1 patient group

Canagliflozin (TA-7284) ＋GLP-1 analogue

Experimental group

Treatment:

Drug: Canagliflozin (TA-7284)

Drug: GLP-1 analogue