Diabetes Mellitus, Type 2 Clinical Trial
Official title:
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
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.
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. ;
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