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

• Status: Completed
• Trial end date: 2016-04-01
• Target enrollment: 0
• Participant gender: All

Summary

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)

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

Details

• Lead Sponsor: Mitsubishi Tanabe Pharma Corporation
• Treatments: Canagliflozin; Insulin; Insulin, Globin Zinc

Criteria

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