CANVAS - CANagliflozin cardioVascular Assessment Study

Completed · Phase 3 · Has a placebo group

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

In brief

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.

Key facts

Study ID

NCT01032629

Run by

Janssen Research & Development, LLC

People needed

4330

Starts

2009-12-09

Expected to finish

2017-02-22

Last updated by the study team

2018-12-07

Who can join

Age: 30 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• Study site — Mesa, Arizona, United States
• Study site — Tucson, Arizona, United States
• Study site — La Mesa, California, United States
• Study site — Los Gatos, California, United States
• Study site — Pismo Beach, California, United States
• Study site — Stockton, California, United States
• Study site — Walnut Creek, California, United States
• Study site — Doral, Florida, United States
• Study site — Fort Lauderdale, Florida, United States
• Study site — Jacksonville, Florida, United States
• Study site — Miami, Florida, United States
• Study site — Plantation, Florida, United States
• Study site — Atlanta, Georgia, United States
• Study site — Duluth, Georgia, United States
• Study site — Boise, Idaho, United States
• Study site — Eagle, Idaho, United States
• Study site — Meridian, Idaho, United States
• Study site — Peoria, Illinois, United States
• Study site — Topeka, Kansas, United States
• Study site — Crestview Hills, Kentucky, United States
• Study site — Lexington, Kentucky, United States
• Study site — Auburn, Maine, United States
• Study site — Scarborough, Maine, United States
• Study site — Oxon Hill, Maryland, United States
• Study site — Birmingham, Alabama, United States

Full record on ClinicalTrials.gov

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