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Cited by 438Diabetes Treatment and ManagementDiabetes, Cardiovascular Risks, and LipoproteinsDiabetes Management and Research

The DOI matches its Crossref record; 23 of the 23 references it cites were found in a registry or an index.

Oral Semaglutide and Cardiovascular Outcomes in High-Risk Type 2 Diabetes

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McGuire, Darren K., Marx, Nikolaus, Mulvagh, Sharon L., Deanfield, John E., Inzucchi, Silvio E., Pop-Busui, Rodica, Mann, Johannes F.E., Emerson, Scott S., Poulter, Neil R., Engelmann, Mads D.M., Ripa, Maria Sejersten, Hovingh, G. Kees, Brown-Frandsen, Kirstine, Bain, Stephen C., Cavender, Matthew A., Gislum, Mette, David, Jens-Peter, Buse, John B.·2025·New England Journal of Medicine
DOI 10.1056/nejmoa2501006
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Abstract

BACKGROUND: The cardiovascular safety of oral semaglutide, a glucagon-like peptide 1 receptor agonist, has been established in persons with type 2 diabetes and high cardiovascular risk. An assessment of the cardiovascular efficacy of oral semaglutide in persons with type 2 diabetes and atherosclerotic cardiovascular disease, chronic kidney disease, or both is needed. METHODS: In this double-blind, placebo-controlled, event-driven, superiority trial, we randomly assigned participants who were 50 years of age or older, had type 2 diabetes with a glycated hemoglobin level of 6.5 to 10.0%, and had known atherosclerotic cardiovascular disease, chronic kidney disease, or both to receive either once-daily oral semaglutide (maximal dose, 14 mg) or placebo, in addition to standard care. The primary outcome was major adverse cardiovascular events (a composite of death from cardiovascular causes, nonfatal myocardial infarction, or nonfatal stroke), assessed in a time-to-first-event analysis. The confirmatory secondary outcomes included major kidney disease events (a five-point composite outcome). RESULTS: Among the 9650 participants who had undergone randomization, the mean (±SD) follow-up was 47.5±10.9 months, and the median follow-up was 49.5 months. A primary-outcome event occurred in 579 of the 4825 participants (12.0%; incidence, 3.1 events per 100 person-years) in the oral semaglutide group, as compared with 668 of the 4825 participants (13.8%; incidence, 3.7 events per 100 person-years) in the placebo group (hazard ratio, 0.86; 95% confidence interval, 0.77 to 0.96; P = 0.006). The results for the confirmatory secondary outcomes did not differ significantly between the two groups. The incidence of serious adverse events was 47.9% in the oral semaglutide group and 50.3% in the placebo group; the incidence of gastrointestinal disorders was 5.0% and 4.4%, respectively. CONCLUSIONS: Among persons with type 2 diabetes and atherosclerotic cardiovascular disease, chronic kidney disease, or both, the use of oral semaglutide was associated with a significantly lower risk of major adverse cardiovascular events than placebo, without an increase in the incidence of serious adverse events. (Funded by Novo Nordisk; SOUL ClinicalTrials.gov number, NCT03914326.).

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  1. Magliano DJ, Boyko EJ. IDF diabetes atlas. 10th ed. Brussels: International Diabetes Federation, 2021.

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Metadata

Authors
McGuire, D. K., Marx, N., Mulvagh, S. L., Deanfield, J. E., Inzucchi, S. E., Pop-Busui, R., Mann, J. F. E., Emerson, S. S., Poulter, N. R., Engelmann, M. D. M., Ripa, M. S., Hovingh, G. K., Brown-Frandsen, K., Bain, S. C., Cavender, M. A., Gislum, M., David, J.-P., & Buse, J. B.
Affiliations
  • Parkland Health & Hospital System (US)
  • Universitätsklinikum Aachen (DE)
  • Dalhousie University (CA)
  • University College London (GB)
  • Yale University (US)
  • Division of Endocrinology, Diabetes, and Clinical Nutrition, Oregon Health and Science University, Portland
  • Friedrich-Alexander-Universität Erlangen-Nürnberg (DE)
  • University of Washington (US)
  • Imperial College London (GB)
  • Novo Nordisk (Denmark) (DK)
  • Novo Nordisk, Søborg, Denmark
  • Swansea University (GB)
  • University of North Carolina at Chapel Hill (US)
ORCID
Venue
New England Journal of Medicine
Publisher
Massachusetts Medical Society
Published
2025-05-29
Volume
392
Issue
20
Pages
2001-2012
ISSN
  • 0028-4793 (ISSN-L)
  • 1533-4406
DOI
10.1056/nejmoa2501006
OpenAlex
W4408960945
Cited by
416
References
23
Citations by year
2026: 263 · 2025: 153
FWCI
283.71
Type
journal article
Language
en
Open access
Licence
Locations
  • New England Journal of Medicine (publishedVersion)
  • PubMed (publishedVersion)
  • Pure Amsterdam UMC (publishedVersion, other-oa)
  • RWTH Publications (RWTH Aachen) (submittedVersion)
Funders
Novo Nordisk (n/a)
Topics
  • Health Sciences › Medicine › Endocrinology, Diabetes and Metabolism › Diabetes Treatment and Management
  • Health Sciences › Medicine › Endocrinology, Diabetes and Metabolism › Diabetes, Cardiovascular Risks, and Lipoproteins
  • Health Sciences › Medicine › Endocrinology, Diabetes and Metabolism › Diabetes Management and Research
Keywords
oral semaglutide, type 2 diabetes, major adverse cardiovascular events, atherosclerotic cardiovascular disease, chronic kidney disease, GLP-1 receptor agonists, cardiovascular safety, kidney disease progression, serious adverse events, gastrointestinal adverse effects, older adults, HbA1c, myocardial infarction, stroke, cardiovascular mortality
MeSH terms
Glucagon-Like Peptide-1 Receptor Agonists, Semaglutide, Administration, Oral, Aged, Cardiovascular Diseases, Diabetes Mellitus, Type 2, Double-Blind Method, Female, Follow-Up Studies, Glycated Hemoglobin, Humans, Male, Middle Aged, Atherosclerosis, Renal Insufficiency, Chronic, Glucagon-Like Peptide 1

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