Effects of oral semaglutide on cardiovascular outcomes in individuals with type 2 diabetes and established atherosclerotic cardiovascular disease and/or chronic kidney disease: Design and baseline characteristics of SOUL , a randomized trial
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Abstract Aim To describe the design of the SOUL trial (Semaglutide cardiOvascular oUtcomes triaL) and the baseline clinical data of its participants. Materials and methods In SOUL, the effects of oral semaglutide, the first oral glucagon‐like peptide‐1 receptor agonist, on the risk of cardiovascular (CV) events in individuals with type 2 diabetes and established atherosclerotic CV disease (ASCVD) and/or chronic kidney disease (CKD) will be assessed. SOUL is a randomized, double‐blind, parallel‐group, placebo‐controlled CV outcomes trial comparing oral semaglutide (14 mg once daily) with placebo, both in addition to standard of care, in individuals aged ≥50 years with type 2 diabetes and evidence of ASCVD (coronary artery disease [CAD], cerebrovascular disease, symptomatic peripheral arterial disease [PAD]) and/or CKD (estimated glomerular filtration rate <60 mL/min/1.73 m 2 ). The primary outcome is time from randomization to first occurrence of a major adverse CV event (MACE; a composite of CV death, nonfatal myocardial infarction or nonfatal stroke). This event‐driven trial will continue until 1225 first adjudication‐confirmed MACEs have occurred. Enrolment has been completed. Results Overall, 9650 participants were enrolled between June 17, 2019 and March 24, 2021 (men 71.1%, White ethnicity 68.9%, mean age 66.1 years, diabetes duration 15.4 years, body mass index 31.1 kg/m 2 , glycated haemoglobin 63.5 mmol/mol [8.0%]). The most frequently used antihyperglycaemic medications at baseline were metformin (75.7%), insulin and insulin analogues (50.5%), sulphonylureas (29.1%), sodium‐glucose cotransporter‐2 inhibitors (26.7%) and dipeptidyl peptidase‐4 inhibitors (23.0%). At randomization, 70.7% of participants had CAD, 42.3% had CKD, 21.1% had cerebrovascular disease and 15.7% had symptomatic PAD (categories not mutually exclusive). Prevalent heart failure was reported in 23.0% of participants. Conclusion SOUL will provide evidence regarding the CV effects of oral semaglutide in individuals with type 2 diabetes and established ASCVD and/or CKD.
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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 [259]
The Introduction reports that PIONEER 6 found a significant reduction in cardiovascular death with oral semaglutide versus placebo. It also says the trial demonstrated cardiovascular safety but was not powered to formally assess cardiovascular efficacy, so the unqualified claim of demonstrated cardiovascular benefit overstates what this source establishes. (LLM, conf=0.86)
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- Authors
- McGuire, D. K., Busui, R. P., Deanfield, J., Inzucchi, S. E., Mann, J. F. E., Marx, N., Mulvagh, S. L., Poulter, N., Engelmann, M. D. M., Hovingh, G. K., Ripa, M. S., Gislum, M., Brown‐Frandsen, K., & Buse, J. B.
- Affiliations
- Parkland Health & Hospital System (US)
- Department of Internal Medicine, Metabolism, Endocrinology and Diabetes University of Michigan Ann Arbor Michigan USA
- University College London (GB)
- Yale University (US)
- Friedrich-Alexander-Universität Erlangen-Nürnberg (DE)
- Universitätsklinikum Aachen (DE)
- Dalhousie University (CA)
- Imperial College London (GB)
- Novo Nordisk (Denmark) (DK)
- University of North Carolina at Chapel Hill (US)
- Corresponding author
- McGuire, Darren K.
- ORCID
- Venue
- Diabetes, Obesity and Metabolism
- Publisher
- Wiley
- Published
- 2023-04-11
- Volume
- 25
- Issue
- 7
- Pages
- 1932-1941
- ISSN
- 1462-8902 (ISSN-L)
- 1463-1326
- OpenAlex
- W4353021269
- Cited by
- 131
- References
- 37
- Citations by year
- 2026: 17 · 2025: 44 · 2024: 52 · 2023: 17
- FWCI
- 26.67
- Type
- journal article
- Language
- en
- Open access
- hybrid
- doi.org
- Licence
- Locations
- Diabetes Obesity and Metabolism (publishedVersion, cc-by-nc-nd)
- PubMed (publishedVersion)
- RWTH Publications (RWTH Aachen) (publishedVersion, other-oa)
- Deep Blue (University of Michigan) (submittedVersion)
- UCL Discovery (University College London) (submittedVersion, cc-by-nc-nd)
- Pure Amsterdam UMC (submittedVersion, cc-by)
- Data Archiving and Networked Services (DANS) (submittedVersion, other-oa)
- RWTH Publications (RWTH Aachen)
- Funders
- Novo Nordisk
- 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 › Cardiology and Cardiovascular Medicine › Heart Failure Treatment and Management
- Keywords
- oral semaglutide, type 2 diabetes, atherosclerotic cardiovascular disease, chronic kidney disease, major adverse cardiovascular events, GLP-1 receptor agonists, SOUL trial, coronary artery disease, peripheral arterial disease, cerebrovascular disease, baseline characteristics, cardiovascular outcomes, trial design, older adults
- MeSH terms
- Sodium-Glucose Transporter 2 Inhibitors, Semaglutide, Aged, Cardiovascular Diseases, Coronary Artery Disease, Diabetes Mellitus, Type 2, Glucagon-Like Peptides, Humans, Hypoglycemic Agents, Male, Randomized Controlled Trials as Topic, Atherosclerosis, Renal Insufficiency, Chronic, Insulins
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