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.
Male
Humans
Aged
Diabetes Mellitus, Type 2
/ complications
Cardiovascular Diseases
/ complications
Sodium-Glucose Transporter 2 Inhibitors
/ therapeutic use
Hypoglycemic Agents
/ adverse effects
Glucagon-Like Peptides
/ adverse effects
Renal Insufficiency, Chronic
/ complications
Atherosclerosis
/ complications
Coronary Artery Disease
Insulins
GLP-1
cardiovascular disease
randomized trial
semaglutide
type 2 diabetes
Journal
Diabetes, obesity & metabolism
ISSN: 1463-1326
Titre abrégé: Diabetes Obes Metab
Pays: England
ID NLM: 100883645
Informations de publication
Date de publication:
07 2023
07 2023
Historique:
revised:
10
03
2023
received:
13
01
2023
accepted:
16
03
2023
medline:
5
6
2023
pubmed:
23
3
2023
entrez:
22
3
2023
Statut:
ppublish
Résumé
To describe the design of the SOUL trial (Semaglutide cardiOvascular oUtcomes triaL) and the 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. 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 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 SOUL will provide evidence regarding the CV effects of oral semaglutide in individuals with type 2 diabetes and established ASCVD and/or CKD.
Substances chimiques
semaglutide
53AXN4NNHX
Sodium-Glucose Transporter 2 Inhibitors
0
Hypoglycemic Agents
0
Glucagon-Like Peptides
62340-29-8
Insulins
0
Types de publication
Randomized Controlled Trial
Journal Article
Research Support, Non-U.S. Gov't
Langues
eng
Sous-ensembles de citation
IM
Pagination
1932-1941Informations de copyright
© 2023 The Authors. Diabetes, Obesity and Metabolism published by John Wiley & Sons Ltd.
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