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A Randomized, Multicenter, Double-Blind, Parallel, Placebo-Controlled Study of the Effects of JNJ 28431754 on Cardiovascular Outcomes in Adult Subjects With Type 2 Diabetes Mellitus (CANVAS: CANagliflozin cardioVascular Assessment Study)

A Randomized, Multicenter, Double-Blind, Parallel, Placebo-Controlled Study of the Effects of JNJ 28431754 on Cardiovascular Outcomes in Adult Subjects With Type 2 Diabetes Mellitus (CANVAS: CANagliflozin cardioVascular Assessment Study)

Status
Active, not recruiting
Phases
Phase 3
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2010/091/000410
Enrollment
4500
Registered
2010-05-11
Start date
Unknown
Completion date
Unknown
Last updated
2021-11-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Health Condition 1: E135- Other specified diabetes mellituswith circulatory complications

Interventions

Intervention1: Canagliflozin: 100 or 300 mg once daily for up to 4 years or longer for individual patients Control Intervention1: Placebo: once daily for up to 4 years or longer for individual patient

Sponsors

Janssen Research Development LLC
Lead Sponsor
Johnson and Johnson Private Limited
Collaborator

Eligibility

Inclusion criteria

Inclusion criteria: Age 30 Years and older Patients must have a diagnosis of T2DM and a history of or a high risk for CV disease Patients must have inadequate diabetes control (as defined by HbA1c 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

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

Design outcomes

Primary

MeasureTime frame
Major adverse cardiovascular events, including CV death, nonfatal MI, and nonfatal strokeTimepoint: Time to event (approximately 4 years)—

Secondary

MeasureTime frame
a standard measure of fasting insulin secretionTimepoint: end of treatment (approximately 4 years);effectiveness of lowering blood glucose (in substudies of patients who are also taking specific commonly-used diabetes agents)Timepoint: 18 weeks;progression of albumin in the urineTimepoint: end of treatment (approximately 4 years)—

Countries

Argentina, Australia, Belgium, Canada, Colombia, Czech Republic, Estonia, Germany, Hungary, India, Israel, Luxembourg, Malaysia, Mexico, Netherlands, New Zealand, Norway, Poland, Russian Federation, Spain, Sweden, Ukraine, United States of America

Contacts

Public ContactDr Jitendra R Dixit MD

Head Global Clinical Operations India

jdixit@its.jnj.com9167068006

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 4, 2026