DEVOTE
Trial question
Is degludec noninferior to glargine among patients with T2DM who are at high risk for CV events?
Study design
Multi-center
Double blinded
RCT
Population
Characteristics of study participants
37.0% female
63.0% male
N = 7637
7637 patients (2859 female, 4778 male).
Inclusion criteria: patients with T2DM at high risk of CV 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; pregnancy or lactation; 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).
N=3819 insulin glargine (10 ml vial containing 100 U/mL once daily between dinner and bedtime).
Primary outcome
Major CV events
8.5%
9.3%
9.3 %
7.0 %
4.7 %
2.3 %
0.0 %
Insulin
degludec
Insulin
glargine
Difference not exceeding
non-inferiority
margin ✓
Difference not exceeding non-inferiority margin in major CV 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 CV 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.
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