Oral semaglutide and cardiovascular outcomes in people with type 2 diabetes, according to SGLT2i use: prespecified analyses of the SOUL randomized trial
Open accessAbstract
BACKGROUND: Both GLP-1 (glucagon-like peptide-1) receptor agonists and SGLT2 (sodium-glucose cotransporter-2) inhibitors (SGLT2i) improve cardiovascular outcomes in people with type 2 diabetes and cardiovascular or chronic kidney disease. However, there are limited data about the effect of combining these agents on cardiovascular and safety outcomes. METHODS: The SOUL trial (Semaglutide Cardiovascular Outcomes Trial; NCT03914326) randomized 9650 participants with type 2 diabetes and atherosclerotic cardiovascular disease and/or chronic kidney disease to oral semaglutide or placebo. As prespecified, participants were analyzed according to baseline use of SGLT2i (yes, n=2596; no, n=7054), and subsequently for any use of SGLT2i during the trial (yes, n=4718; no, n=4932). The primary outcome was time to first major adverse cardiovascular event, defined as cardiovascular death, nonfatal myocardial infarction, or nonfatal stroke. Safety was evaluated by comparing the incidence of serious adverse events. RESULTS: Over a mean follow-up of 47.5±10.9 months, the risk of the primary outcome in the overall trial population was 14% lower for oral semaglutide versus placebo (hazard ratio, 0.86; 95% CI, 0.77–0.96). In those taking SGLT2i at baseline, there were 143 of 1296 (semaglutide) versus 158 of 1300 (placebo) primary outcome events (hazard ratio, 0.89; 95% CI, 0.71–1.11); and 436 of 3529 versus 510 of 3525, respectively, in participants not taking SGLT2i at baseline (hazard ratio, 0.84; 95% CI, 0.74–0.95; P -interaction, 0.66). An analysis of major adverse cardiovascular events by any in-trial SGLT2i use versus no use also showed no evidence of heterogeneity in the effects of oral semaglutide. The adverse event profiles of oral semaglutide with or without concomitant SGLT2i were similar. CONCLUSIONS: Oral semaglutide reduced major adverse cardiovascular event outcomes independently of concomitant SGLT2i treatment, and this combination appeared to be safe. REGISTRATION: URL: https://www.clinicaltrials.gov ; Unique identifier: NCT03914326.
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An oral formulation of semaglutide has also demonstrated cardiovascular benefit.
“An oral formulation of semaglutide has also demonstrated cardiovascular benefit (257–259).”
From 10. Cardiovascular Disease and Risk Management: Standards of Care in Diabetes—2026 (2026) · cites this paper as [257]
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- Authors
- Marx, N., Deanfield, J. E., Mann, J. F. E., Arechavaleta, R., Bain, S. C., Bajaj, H. S., Bayer Tanggaard, K., Birkenfeld, A. L., Buse, J. B., Davicevic-Elez, Z., Desouza, C., Emerson, S. S., Engelmann, M. D. M., Hovingh, G. K., Inzucchi, S. E., Jhund, P. S., Mulvagh, S. L., Pop-Busui, R., Poulter, N. R., Rasmussen, S., Tu, S.-T., McGuire, D. K., & on behalf of the SOUL Study Group
- Affiliations
- Universitätsklinikum Aachen (DE)
- University College London (GB)
- Friedrich-Alexander-Universität Erlangen-Nürnberg (DE)
- Universidad Autónoma de Guadalajara (MX)
- Swansea University (GB)
- LMC Diabetes & Endocrinology (Canada) (CA)
- Novo Nordisk A/S, Søborg, Denmark (K.B.-T., Z.D.-E., M.D.M.E., G.K.H., S.R.).
- Helmholtz Munich (DE)
- University of North Carolina at Chapel Hill (US)
- University of Nebraska Medical Center (US)
- University of Washington (US)
- Novo Nordisk (Denmark) (DK)
- Yale University (US)
- British Heart Foundation (GB)
- Dalhousie University (CA)
- Division of Endocrinology, Diabetes and Clinical Nutrition, Department of Medicine, Oregon Health and Science University, Portland (R.P.-B.).
- Imperial College London (GB)
- Changhua Christian Hospital (TW)
- Parkland Health & Hospital System (US)
- Corresponding author
- Marx, Nikolaus
- ORCID
- Venue
- Circulation
- Published
- 2025-06-10
- Volume
- 151
- Issue
- 23
- Pages
- 1639-1650
- ISSN
- 0009-7322 (ISSN-L)
- 1524-4539
- PMC
- PMC12144549
- OpenAlex
- W4408960834
- Cited by
- 70
- References
- 28
- Citations by year
- 2026: 49 · 2025: 21
- FWCI
- 47.74
- Type
- journal article
- Language
- en
- Open access
- hybrid
- doi.org
- Licence
- Locations
- Circulation (publishedVersion, cc-by-nc-nd)
- PubMed Central (publishedVersion, cc-by-nc-nd)
- PubMed (publishedVersion)
- Pure Amsterdam UMC (submittedVersion, other-oa)
- RWTH Publications (RWTH Aachen) (submittedVersion, other-oa)
- Funders
- Novo Nordisk A/S (n/a)
- Topics
- Health Sciences › Medicine › Endocrinology, Diabetes and Metabolism › Diabetes Treatment and Management
- Health Sciences › Medicine › Cardiology and Cardiovascular Medicine › Heart Failure Treatment and Management
- Health Sciences › Medicine › Endocrinology, Diabetes and Metabolism › Diabetes, Cardiovascular Risks, and Lipoproteins
- Keywords
- SGLT2 inhibitors, type 2 diabetes, major adverse cardiovascular events, cardiovascular safety, atherosclerotic cardiovascular disease, chronic kidney disease, GLP-1 receptor agonists, drug interactions, SOUL trial, serious adverse events, myocardial infarction, stroke, cardiovascular mortality, renal safety, hypoglycemia, gastrointestinal adverse effects
- MeSH terms
- Sodium-Glucose Transporter 2 Inhibitors, Semaglutide, Administration, Oral, Aged, Cardiovascular Diseases, Diabetes Mellitus, Type 2, Glucagon-Like Peptides, Female, Humans, Male, Middle Aged, Treatment Outcome, Glucagon-Like Peptide 1
About these checks
Registry, retraction, Cites and statistics results are computed, not judged, with one exception: a printed reference that no index lists is read once by a model before it counts as a citation error. Claims are extracted by a model and kept only when their quote appears verbatim in the text; each cited source is then checked, with a model’s help, for whether it says what the claim relies on. Those verdicts can be wrong — read the claim’s quote and the cited source before relying on one.
Statistics and arithmetic are recomputed, not judged.
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