CANVAS - CANagliflozin cardioVascular Assessment Study (CANVAS)
Diabetes Mellitus, Type 2, Cardiovascular Diseases, Risk Factors
About this trial
This is an interventional treatment trial for Diabetes Mellitus, Type 2 focused on measuring Diabetes, Type 2 diabetes mellitus, Cardiovascular risk, Cardiovascular outcomes, Canagliflozin (JNJ-28431754), Placebo
Eligibility Criteria
Inclusion Criteria:
- Patients must have a diagnosis of type 2 diabetes mellitus and greater than or equal to (>=) 30 yrs old with history of cardiovascular (CV) event, or >= 50 yrs old with high risk of CV events
- Patients must have inadequate diabetes control (as defined by glycosylated hemoglobin greater than or equal to 7.0% to less than or equal to 10.5% at screening) and be either (1) not currently on diabetes drug therapy or (2) on therapy with any approved class of diabetes drugs
Exclusion Criteria:
- A history of diabetic ketoacidosis, type 1 diabetes mellitus, pancreas or beta-cell transplantation, or diabetes secondary to pancreatitis or pancreatectomy
- History of one or more severe hypoglycemic (ie, very low blood sugar) episode within 6 months before screening
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm 3
Placebo Comparator
Experimental
Experimental
Placebo
Canagliflozin (JNJ-28431754) 100 mg
Canagliflozin (JNJ-28431754) 300 mg
Each patient will receive placebo (inactive medication) on background standard of care for diabetes once daily for the duration of the study
Each patient will receive canagliflozin (JNJ-28431754) 100 mg once daily on background standard of care for diabetes once daily for the duration of the study
Each patient will receive canagliflozin (JNJ-28431754) 300 mg once daily on background standard of care for diabetes once daily for the duration of the study