TY - JOUR
T1 - Effects of oral semaglutide on cardiovascular outcomes in individuals with type 2 diabetes and established atherosclerotic cardiovascular disease and/or chronic kidney disease
T2 - Design and baseline characteristics of SOUL, a randomized trial
AU - McGuire, Darren K.
AU - Busui, Rodica P.
AU - Deanfield, John
AU - Inzucchi, Silvio E.
AU - Mann, Johannes F. E.
AU - Marx, Nikolaus
AU - Mulvagh, Sharon L.
AU - Poulter, Neil
AU - Engelmann, Mads D. M.
AU - Hovingh, G. Kees
AU - Ripa, Maria Sejersten
AU - Gislum, Mette
AU - Brown-Frandsen, Kirstine
AU - Buse, John B.
N1 - Funding Information:
We would like to thank the patients participating in this trial, the investigators, all trial site staff and all Novo Nordisk A/S employees involved in the trial. We thank Emisphere Technology (Roseland, New Jersey) for providing a licence to the Eligen Technology, the SNAC component of oral semaglutide. Editorial support was provided by Graham Allcock, PhD, CMPP, from Axis, a division of Spirit Medical Communications Group Limited, funded by Novo Nordisk A/S, in accordance with Good Publication Practice 3 (GPP3) guidelines (www.ismpp.org/gpp3). This trial was funded, designed, initiated and conducted by Novo Nordisk (Søborg, Denmark).
Funding Information:
We would like to thank the patients participating in this trial, the investigators, all trial site staff and all Novo Nordisk A/S employees involved in the trial. We thank Emisphere Technology (Roseland, New Jersey) for providing a licence to the Eligen Technology, the SNAC component of oral semaglutide. Editorial support was provided by Graham Allcock, PhD, CMPP, from Axis, a division of Spirit Medical Communications Group Limited, funded by Novo Nordisk A/S, in accordance with Good Publication Practice 3 (GPP3) guidelines ( www.ismpp.org/gpp3 ). This trial was funded, designed, initiated and conducted by Novo Nordisk (Søborg, Denmark).
Publisher Copyright:
© 2023 The Authors. Diabetes, Obesity and Metabolism published by John Wiley & Sons Ltd.
PY - 2023/7
Y1 - 2023/7
N2 - 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 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. 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/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. Conclusion: SOUL will provide evidence regarding the CV effects of oral semaglutide in individuals with type 2 diabetes and established ASCVD and/or CKD.
AB - 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 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. 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/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. Conclusion: SOUL will provide evidence regarding the CV effects of oral semaglutide in individuals with type 2 diabetes and established ASCVD and/or CKD.
KW - cardiovascular disease
KW - GLP-1
KW - randomized trial
KW - semaglutide
KW - type 2 diabetes
UR - https://www.scopus.com/pages/publications/85152782621
U2 - 10.1111/dom.15058
DO - 10.1111/dom.15058
M3 - Article
C2 - 36945734
SN - 1462-8902
VL - 25
SP - 1932
EP - 1941
JO - Diabetes, Obesity and Metabolism
JF - Diabetes, Obesity and Metabolism
IS - 7
ER -
SDG 3 Good Health and Well-being