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

• Status: Completed
• Trial end date: 2016-03-01
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Mitsubishi Tanabe Pharma Corporation
• Treatments: Canagliflozin; Glucagon; Glucagon-Like Peptide 1

Criteria

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