CANagliflozin Treatment And Trial Analysis-Sulfonylurea (CANTATA-SU) SGLT2 Add-on to Metformin Versus Glimepiride

• Status: Completed
• Trial end date: 2013-01-01
• Target enrollment: 0
• Participant gender: All

Summary

The purpose of this study is to demonstrate the efficacy, safety, and tolerability of canagliflozin (JNJ-28431754) compared with glimepiride in patients with type 2 diabetes mellitus with inadequate control despite treatment with metformin.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Janssen Research & Development, LLC
• Treatments: Canagliflozin; Glimepiride; Metformin

Criteria

Inclusion Criteria:

• Patients must have a diagnosis of type 2 diabetes

• Body mass index (BMI) >=22 to <=45 kg/m2, at screening

• Patients must be taking a stable dosage of metformin as monotherapy at screening

• Patients must have a HbA1c between >=7% and <=9.5% at Week 2

• Patients must have a fasting plasma glucose (FPG) <=270 mg/dL (15 mmol/L) at Week -2

Exclusion Criteria:

• Patients having prior exposure or known contraindication or suspected hypersensitivity to JNJ-28431754, glimepiride, or metformin

• History of diabetic ketoacidosis or type 1 diabetes mellitus

• History of pancreas or beta-cell transplantation

• History of active proliferative diabetic retinopathy

• History of hereditary glucose-galactose malabsorption or primary renal glucosuria

• Renal disease requiring treatment with immunosuppressive therapy within the past 12 months before screening or a history of dialysis or renal transplant

• Taken thiazolidinedione therapy in the past 16 weeks before screening