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Cited by 131Diabetes Treatment and ManagementDiabetes, Cardiovascular Risks, and LipoproteinsHeart Failure Treatment and Management

The DOI matches its Crossref record; 37 of the 37 references it cites were found in a registry or an index.

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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McGuire, Darren K., Busui, Rodica P., Deanfield, John, Inzucchi, Silvio E., Mann, Johannes F. E., Marx, Nikolaus, Mulvagh, Sharon L., Poulter, Neil, Engelmann, Mads D. M., Hovingh, G. Kees, Ripa, Maria Sejersten, Gislum, Mette, Brown‐Frandsen, Kirstine, Buse, John B.·2023·Diabetes, Obesity and Metabolism
DOI 10.1111/dom.15058
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Abstract

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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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
DOI
10.1111/dom.15058
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
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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