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

Author:

McGuire Darren K.1,Busui Rodica P.2,Deanfield John3,Inzucchi Silvio E.4ORCID,Mann Johannes F. E.56ORCID,Marx Nikolaus7,Mulvagh Sharon L.8,Poulter Neil9,Engelmann Mads D. M.10,Hovingh G. Kees10,Ripa Maria Sejersten10,Gislum Mette10,Brown‐Frandsen Kirstine10ORCID,Buse John B.11

Affiliation:

1. University of Texas Southwestern Medical Center, and Parkland Health and Hospital System Dallas Texas USA

2. Department of Internal Medicine, Metabolism, Endocrinology and Diabetes University of Michigan Ann Arbor Michigan USA

3. Institute of Cardiovascular Sciences, University College London London UK

4. Section of Endocrinology, Yale School of Medicine New Haven Connecticut USA

5. KfH Kidney Center Munich Germany

6. Friedrich Alexander University of Erlangen Erlangen Germany

7. Department of Internal Medicine I University Hospital Aachen, RWTH Aachen University Aachen Germany

8. Department of Medicine, Division of Cardiology Dalhousie University Halifax Nova Scotia Canada

9. Imperial Clinical Trials Unit, Imperial College London London UK

10. Novo Nordisk A/S Søborg Denmark

11. University of North Carolina School of Medicine Chapel Hill North Carolina USA

Abstract

AbstractAimTo describe the design of the SOUL trial (Semaglutide cardiOvascular oUtcomes triaL) and the baseline clinical data of its participants.Materials and methodsIn 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 m2). 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.ResultsOverall, 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/m2, 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.ConclusionSOUL will provide evidence regarding the CV effects of oral semaglutide in individuals with type 2 diabetes and established ASCVD and/or CKD.

Publisher

Wiley

Subject

Endocrinology,Endocrinology, Diabetes and Metabolism,Internal Medicine

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