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Efficacy and safety of degludec versus glargine in type 2 diabetes.

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Marso, Steven P., McGuire, Darren K., Zinman, Bernard, Poulter, Neil R., Emerson, Scott S., Pieber, Thomas R., Pratley, Richard E., Haahr, Poul-Martin, Lange, Martin, Brown-Frandsen, Kirstine, Moses, Alan, Skibsted, Simon, Kvist, Kajsa, Buse, John B.·2017·New England Journal of Medicine

DOI 10.1056/nejmoa1615692PMC PMC5731244

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Abstract

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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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: McGuire, Darren K.
Zinman, Bernard
Poulter, Neil R.
Emerson, Scott S.
Pieber, Thomas R.
Pratley, Richard E.
Lange, Martin
Kvist, Kajsa
Buse, John B.
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
DOI: 10.1056/nejmoa1615692
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
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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Efficacy and safety of degludec versus glargine in type 2 diabetes.

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