6/28/23, 12:02 AM CANVAS Pathway Feedback Search Clinical Topics Home Studies CANVAS CANVAS Disease Diabetes mellitus type 2 Trial question What is the effect of canagliflozin in patients with T2DM and high cardiovascular risk? Study design Multi-center Single blinded RCT Population Characteristics of study participants 36.0% female N = 10142 64.0% male 10142 patients (3633 female, 6509 male) Inclusion criteria: patients with T2DM and high cardiovascular risk Key exclusion criteria: history of diabetic ketoacidosis, TIDM, pancreas or -cell transplantation, renal disease requiring treatment with immunosuppressive therapy, history of chronic dialysis or renal transplant Interventions N=5795 canagliflozin (at a dose of 300 mg or 100 mg in CANVAS and initial dose of 100 mg daily with an optional increase to 300 mg starting from week 13 in CANVAS-R) N=4347 placebo (matching placebo) Primary outcome Death from cardiovascular causes, nonfatal myocardial infarction, or nonfatal stroke 31.5 31.5 26.9 23 6 https://web.pathway.md/studies/recW41JzdOCKZqNyb 1/2 6/28/23, 12:02 AM CANVAS Pathway 23.6 15.8 7.9 Significant decrease 0.0 Canagliflozin Placebo Significant decrease in death from cardiovascular causes, nonfatal myocardial infarction, or nonfatal stroke (26.9 vs. 31.5; HR 0.86, 95% CI 0.75 to 0.97) Secondary outcomes Borderline significant decrease in progression of albuminuria (89.4 vs. 128.7; HR 0.73, 95% CI 0.67 to 0.79) Safety outcomes No significant differences in adverse events leading to discontinuation (35.5 vs. 32.8 participants per 1,000 patient-years; HR 1.13, 95% CI 0.99-1.28). Significant differences in risk of amputation of toes, feet, or legs (6.3 vs. 3.4 participants per 1,000 patient-years; HR 1.97, 95% CI 1.41-2.75) and serious adverse events (104.3 vs. 120.0 participants per 1,000 patient-years; HR 0.93, 95% CI 0.87-1.00). Conclusion In patients with T2DM and high cardiovascular risk, canagliflozin was superior to placebo with respect to death from cardiovascular causes, nonfatal myocardial infarction, or nonfatal stroke. Reference Neal B, Perkovic V, Mahaffey KW et al. Canagliflozin and Cardiovascular and Renal Events in Type 2 Diabetes. N Engl J Med. 2017 Aug 17;377(7):644-657. Open reference URL https://web.pathway.md/studies/recW41JzdOCKZqNyb 2/2