The CANTATA-M (CANagliflozin Treatment and Trial Analysis - Monotherapy) Trial

• Status: Completed
• Trial end date: 2012-03-01
• Target enrollment: 0
• Participant gender: All

Summary

The purpose of this study is to evaluate the efficacy, safety, and tolerability of 2 different doses of canagliflozin administered as monotherapy compared with placebo in patients with type 2 diabetes mellitus (T2DM) inadequately controlled with diet and exercise.

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

Details

• Lead Sponsor: Janssen Research & Development, LLC
• Treatments: Canagliflozin; Sitagliptin Phosphate

Criteria

Inclusion Criteria:

• All patients must have a diagnosis of T2DM

• Patients in the main study must have a Hemoglobin A1c (HbA1c) between >=7% and <=10% and a fasting plasma glucose (FPG) <270 mg/dL (15 mmol/L)

• Patients in the High Glycemic Cohort Substudy must have an HbA1c between >10% and <=12% and a FPG <=350 mg/dL (19.44 mmol/L)

Exclusion Criteria:

• History of diabetic ketoacidosis, type 1 diabetes mellitus (T1DM), pancreas or beta cell transplantation, diabetes secondary to pancreatitis or pancreatectomy, or a severe hypoglycemic episode within 6 months before screening