Efficacy and safety of degludec versus glargine in type 2 diabetes.
Open accessAbstract
BACKGROUND: Degludec is an ultralong-acting, once-daily basal insulin that is approved for use in adults, adolescents, and children with diabetes. Previous open-label studies have shown lower day-to-day variability in the glucose-lowering effect and lower rates of hypoglycemia among patients who received degludec than among those who received basal insulin glargine. However, data are lacking on the cardiovascular safety of degludec. METHODS: We randomly assigned 7637 patients with type 2 diabetes to receive either insulin degludec (3818 patients) or insulin glargine U100 (3819 patients) once daily between dinner and bedtime in a double-blind, treat-to-target, event-driven cardiovascular outcomes trial. The primary composite outcome in the time-to-event analysis was the first occurrence of an adjudicated major cardiovascular event (death from cardiovascular causes, nonfatal myocardial infarction, or nonfatal stroke) with a prespecified noninferiority margin of 1.3. Adjudicated severe hypoglycemia, as defined by the American Diabetes Association, was the prespecified, multiplicity-adjusted secondary outcome. RESULTS: Of the patients who underwent randomization, 6509 (85.2%) had established cardiovascular disease, chronic kidney disease, or both. At baseline, the mean age was 65.0 years, the mean duration of diabetes was 16.4 years, and the mean (±SD) glycated hemoglobin level was 8.4±1.7%; 83.9% of the patients were receiving insulin. The primary outcome occurred in 325 patients (8.5%) in the degludec group and in 356 (9.3%) in the glargine group (hazard ratio, 0.91; 95% confidence interval, 0.78 to 1.06; P<0.001 for noninferiority). At 24 months, the mean glycated hemoglobin level was 7.5±1.2% in each group, whereas the mean fasting plasma glucose level was significantly lower in the degludec group than in the glargine group (128±56 vs. 136±57 mg per deciliter, P<0.001). Prespecified adjudicated severe hypoglycemia occurred in 187 patients (4.9%) in the degludec group and in 252 (6.6%) in the glargine group, for an absolute difference of 1.7 percentage points (rate ratio, 0.60; P<0.001 for superiority; odds ratio, 0.73; P<0.001 for superiority). Rates of adverse events did not differ between the two groups. CONCLUSIONS: Among patients with type 2 diabetes at high risk for cardiovascular events, degludec was noninferior to glargine with respect to the incidence of major cardiovascular events. (Funded by Novo Nordisk and others; DEVOTE ClinicalTrials.gov number, NCT01959529 .).
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Both insulin glargine U100 and insulin degludec have demonstrated cardiovascular safety in dedicated cardiovascular outcome trials.
“Both insulin glargine U100 and insulin degludec have demonstrated cardiovascular safety in dedicated CVOTs (207,208).”
Dipeptidyl peptidase-4 inhibitors, sulfonylureas, and insulin were excluded due to lack of current evidence of efficacy in cardiovascular outcome trials.
“The following drug classes were excluded due to lack of current evidence of efficacy in cardiovascular outcome trials: dipeptidyl peptidase-4 inhibitors,19 sulfonylureas,20 and insulin.21,22”
From Cardioprotective Glucose-Lowering Agents and Dementia Risk: A Systematic Review and Meta-Analysis (2025) · cites this paper as [22]
A significantly lower frequency of hypoglycaemia was observed in the degludec arm compared with the glargine arm in the DEVOTE trial.
“A significantly lower frequency of hypoglycaemia was observed in the degludec arm compared with the glargine arm.181”
From 2023 ESC guidelines for the management of cardiovascular disease in patients with diabetes. (2023) · cites this paper as [181]
In the DEVOTE trial, over a median follow-up of 1.8 years, there was no significant difference in the primary composite of cardiovascular death, non-fatal myocardial infarction, or non-fatal stroke between insulin degludec and insulin glargine U100 in patients with type 2 diabetes with atherosclerotic cardiovascular disease or at high cardiovascular risk.
“The DEVOTE (A Trial Comparing Cardiovascular Safety of Insulin Degludec Versus Insulin Glargine in Subjects With Type 2 Diabetes at High Risk of Cardiovascular Events) trial, a randomized, double-blind comparison of the ultra-long-acting, o.d.insulin degludec vs. insulin glargine U100, enrolled 7637 patients with T2DM with ASCVD or at high CV risk.181 Over a median follow-up of 1.8 years, there”
From 2023 ESC guidelines for the management of cardiovascular disease in patients with diabetes. (2023) · cites this paper as [181]
In the DEVOTE trial, insulin degludec compared with glargine reduced the risk of hypoglycaemia, yet this did not translate into any difference in cardiovascular risk.
“For example, insulin degludec compared with glargine in the DEVOTE trial reduced the risk of hypoglycaemia, yet this did not translate into any difference in CV risk.181”
From 2023 ESC guidelines for the management of cardiovascular disease in patients with diabetes. (2023) · cites this paper as [181]
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- Authors
- Marso, S. P., McGuire, D. K., Zinman, B., Poulter, N. R., Emerson, S. S., Pieber, T. R., Pratley, R. E., Haahr, P.-M., Lange, M., Brown-Frandsen, K., Moses, A., Skibsted, S., Kvist, K., & Buse, J. B.
- Affiliations
- Mount Sinai Hospital (CA)
- University of North Carolina at Chapel Hill (US)
- ORCID
- Venue
- New England Journal of Medicine
- Publisher
- Massachusetts Medical Society
- Published
- 2017-08-24
- Volume
- 377
- Issue
- 8
- Pages
- 723-732
- ISSN
- 0028-4793 (ISSN-L)
- 1533-4406
- PMC
- PMC5731244
- OpenAlex
- W2625031949
- Cited by
- 574
- References
- 27
- Citations by year
- 2026: 20 · 2025: 16 · 2024: 41 · 2023: 43 · 2022: 56 · 2021: 61 · 2020: 81 · 2019: 104 · 2018: 100 · 2017: 50 · 2016: 2
- FWCI
- 72.47
- Type
- journal article
- Language
- en
- Open access
- green
- www.ncbi.nlm.nih.gov
- Locations
- New England Journal of Medicine (publishedVersion)
- PubMed (publishedVersion)
- PubMed Central (acceptedVersion)
- IRIS Research product catalog (Sapienza University of Rome) (submittedVersion, other-oa)
- Nova Science Publishers (Nova Science Publishers, Inc.) (submittedVersion)
- Acibadem University Open Access Repository (submittedVersion)
- Spiral (Imperial College London) (submittedVersion)
- Funders
- National Institute for Health and Care Research (NF-SI-0513-10139, NF-SI-0508-10299, RC-PG-0407-10054)
- Versus Arthritis (20639, 18475)
- National Institutes of Health (UL1TR001111, UL1TR002489)
- National Institute of Diabetes and Digestive and Kidney Diseases (T35DK060444, P30DK020541)
- National Center for Advancing Translational Sciences
- Topics
- Health Sciences › Medicine › Endocrinology, Diabetes and Metabolism › Diabetes Treatment and Management
- Health Sciences › Medicine › Endocrinology, Diabetes and Metabolism › Diabetes Management and Research
- Health Sciences › Medicine › Endocrinology, Diabetes and Metabolism › Diabetes, Cardiovascular Risks, and Lipoproteins
- Keywords
- insulin degludec, insulin glargine, type 2 diabetes, basal insulin, cardiovascular safety, major adverse cardiovascular events, severe hypoglycemia, HbA1c, fasting blood glucose, non-inferiority, cardiovascular disease, chronic kidney disease, glycemic variability, insulin duration of action
- MeSH terms
- Insulin Glargine, Aged, Blood Glucose, Cardiovascular Diseases, Diabetes Mellitus, Type 2, Double-Blind Method, Female, Humans, Hypoglycemia, Hypoglycemic Agents, Male, Middle Aged, Incidence, Insulin, Long-Acting, Kaplan-Meier Estimate
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