CANVAS study of canagliflozin Janssen) in Type 2 Diabetes sub study - 04-Oct-2012

CANVAS study, also known as DIA3008, is a prospective, double blind, placebo-controlled trial designed to evaluate the efficacy, tolerability and cardiovascular safety of canagliflozin, a SGLT-2 inhibitor from Janssen Pharma, in 4,330 adult patients with Type 2 Diabetes who are considered at elevated risk for cardiovascular disease.An 18-week sub-study was made of 1,718 patients enrolled in CANVAS who were receiving insulin for an average of 7.1 years. Patients in this sub-study who were randomized to treatment with daily canagliflozin 100 mg or 300 mg, in addition to their usual insulin regimen, had statistically greater A1C reductions at 18 weeks relative to placebo (percent change from baseline, -0.65 and -0.73%, respectively, p<0.001). The overall incidence of treatment-emergent adverse events (AEs) was generally similar across all treatment arms. In a secondary efficacy endpoint measures in the CANVAS study, both the canagliflozin 100 mg and 300 mg dose groups provided reductions in body weight relative to placebo (body weight percent change, -1.9 and -2.4%, respectively, p<0.001).