CANVAS - CANagliflozin cardioVascular Assessment Study

Janssen (J&J Innovative Medicine)

Status and phase: Completed; Phase 3

Conditions: Risk Factors; Cardiovascular Diseases; Diabetes Mellitus, Type 2

Treatments: Drug: Canagliflozin (JNJ-28431754) 300 mg; Drug: Canagliflozin (JNJ-28431754) 100 mg; Drug: Placebo

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT01032629

2009-012140-16 (EudraCT Number)

28431754DIA3008 (Other Identifier)

CR016627

Details and patient eligibility

About

The study will assess canagliflozin (JNJ-28431754) in the treatment of patients with type 2 diabetes mellitus (T2DM) with regard to cardiovascular (CV) risk for major adverse cardiac events (MACE). Other objectives include evaluating the overall safety, tolerability, and effectiveness of canagliflozin.

The data from this study will be combined with the data from CANVAS-R study (Study of the Effects of Canagliflozin on Renal Endpoints in Adult Subjects with T2DM, NCT01989754) in a pre-specified integrated analysis of CV safety outcomes to satisfy US FDA post-marketing requirements for canagliflozin.

Full description

The study will evaluate canagliflozin compared to placebo on CV events including CV death, heart attack, and stroke in patients with T2DM, whose diabetes is not well controlled at the beginning of the study and who have a history of CV events or have a high risk for CV events. The study includes 3 substudies which will compare the effectiveness of lowering blood glucose and assess the safety of canagliflozin relative to placebo in patients receiving specific commonly-used diabetes agents. 4,330 participants will be randomly assigned to treatment with 1 of 2 doses of canagliflozin (100 or 300 mg) or placebo, in a 1:1:1 ratio. This study was originally designed to last for up to 9 years. As per FDA post-marketing requirements for canagliflozin, the study's last subject last visit will now occur when enough MACE events (ie, CV death, nonfatal myocardial infarction, nonfatal stroke) are accumulated between the CANVAS (this study) and CANVAS-R studies. The completion target was reached in February 2017.

Enrollment: 4,330 patients

Sex: All

Ages: 30+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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4,330 participants in 3 patient groups, including a placebo group

Placebo

Placebo Comparator group

Description:

Each patient will receive placebo (inactive medication) on background standard of care for diabetes once daily for the duration of the study

Treatment:

Drug: Placebo

Canagliflozin (JNJ-28431754) 100 mg

Experimental group

Description:

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

Treatment:

Drug: Canagliflozin (JNJ-28431754) 100 mg

Canagliflozin (JNJ-28431754) 300 mg

Experimental group

Description:

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

Treatment:

Drug: Canagliflozin (JNJ-28431754) 300 mg