6/28/23, 1:16 AM DEVOTE Pathway Feedback Search Clinical Topics Home Studies DEVOTE DEVOTE Disease Diabetes mellitus type 2 Trial question Is degludec noninferior to glargine among patients with T2DM who are at high risk for cardiovascular events? Study design Multi-center Double blinded RCT Population Characteristics of study participants 37.0% female N = 7637 63.0% male 7637 patients (2859 female, 4778 male) Inclusion criteria: patients with T2DM at high risk of cardiovascular events on standard care being treated with at least one oral or injectable antihypertensive agent Key exclusion criteria: acute coronary or cerebrovascular event in the previous 60 days, planned coronary, carotid or peripheral artery revascularization, chronic HF NYHA class IV, end-stage liver disease, known or suspected hypersensitivity to trial products or related products, pregnant or breast-feeding women, current or past (within 5 years) malignant neoplasms (except basal cell and SCC) Interventions N=3818 insulin degludec (10 ml vial containing 100 U/mL once daily between dinner and bedtime) https://web.pathway.md/studies/recqDHL5LWOzi1Dyx 1/2 6/28/23, 1:16 AM DEVOTE Pathway N=3819 insulin glargine (10 ml vial containing 100 U/mL once daily between dinner and bedtime) Primary outcome Major cardiovascular events 9.3 % 9.3 8.5 7.0 % 4.7 % Difference not exceeding nonferiority margin 2.3 % 0.0 % Insulin degludec Insulin glargine Difference not exceeding nonferiority margin in major cardiovascular events (8.5% vs. 9.3%; HR 0.91, 95% CI 0.78 to 1.06) Secondary outcomes Significant decrease in severe hypoglycemia (3.7 vs. 6.25; RR 0.6, 95% CI 0.48 to 0.76) Safety outcomes No significant difference in rates of adverse events. Conclusion In patients with T2DM at high risk of cardiovascular events on standard care being treated with at least one oral or injectable antihypertensive agent, insulin degludec was noninferior to insulin glargine with respect to major cardiovascular events. Reference Marso SP, McGuire DK, Zinman B et al. Efficacy and Safety of Degludec versus Glargine in Type 2 Diabetes. N Engl J Med. 2017 Aug 24;377(8):723-732. Open reference URL https://web.pathway.md/studies/recqDHL5LWOzi1Dyx 2/2