An Efficacy, Safety, and Tolerability Study of Canagliflozin (JNJ-28431754) in Patients With Type 2 Diabetes

• Status: Completed
• Trial end date: 2009-01-01
• Target enrollment: 0
• Participant gender: All

Summary

The purpose of this study is to evaluate the effectiveness, safety, and tolerability of JNJ-28431754 compared with placebo in patients with type 2 diabetes.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
• Treatments: Canagliflozin; Sitagliptin Phosphate

Criteria

Inclusion Criteria:

• Patients must have a diagnosis of type 2 diabetes mellitus

• Hemoglobin A1c levels >=7% and <=10.5%

• taking a stable daily dose of metformin

• Body mass index (BMI) 25 to 45 kg/m2 except those of Asian descent who must have a BMI of 24 to 45 kg/m2

• Stable body weight

• Serum creatinine <=1.5 mg/dL (132.6 umol/L) for men and <=1.4 mg/dL (123.76 umol/L) for women

Exclusion Criteria:

• Patients must not have prior exposure or known contraindication or suspected hypersensitivity to canagliflozin (JNJ-28431754)

• Known contraindication or suspected hypersensitivity to sitagliptin or metformin

• A 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