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Effects of oral semaglutide on cardiovascular outcomes in individuals with type 2 diabetes and established atherosclerotic cardiovascular disease and/or chronic kidney disease: SOUL, a randomized trial, design and baseline characteristics.

AIM: To describe the design of Semaglutide cardiOvascular oUtcomes triaL (SOUL) and baseline clinical data of its participants. 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.

MATERIALS AND METHODS: 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 with 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 ).

PRIMARY OUTCOME: time from randomization to first occurrence of a major adverse CV event (MACE; composite of CV death, nonfatal myocardial infarction or nonfatal stroke). This event-driven trial will continue until 1225 first adjudication-confirmed MACEs have occurred. Enrollment has been completed.

RESULTS: Overall, 9650 participants were enrolled between 17 June 2019 and 24 March 2021 (male 71.1%, White 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 co-transporter 2 inhibitors (26.7%) and dipeptidyl peptidase-4 inhibitors (23.0%). At randomization, 70.7% of participants had CAD, 42.3% CKD, 21.1% cerebrovascular disease and 15.7% symptomatic PAD (categories not mutually exclusive). Prevalent heart failure was reported in 23.0% of participants.

CONCLUSIONS: SOUL will provide evidence regarding the CV effects of oral semaglutide in individuals with type 2 diabetes and established ASCVD and/or CKD. This article is protected by copyright. All rights reserved.

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