Study S002179

Semaglutide Cardiovascular Outcomes Trial in Patients With Type 2 Diabetes

Name: LivingGLP1 adjudicated trial data and network meta-analysis results
Creator: Ahmad Sofi-Mahmudi
License: https://creativecommons.org/licenses/by/4.0/

Included trial: extracted data ClinicalTrials.gov record Study Protocol (PDF)Statistical Analysis Plan (PDF)

Registration

Registration: NCT03914326
Acronym: SOUL
Study type: INTERVENTIONAL
Allocation: RANDOMIZED
Phase: PHASE3
Masking: QUADRUPLE
Status: COMPLETED
Enrollment: 9651
Start: 2019-06-17
Primary completion: 2024-08-23
Lead sponsor: Novo Nordisk A/S
Conditions: Diabetes Mellitus, Type 2
Interventions: DRUG:Semaglutide; DRUG:Placebo (semaglutide)
Results posted: TRUE
Individual participant data sharing: YES
Secondary identifiers: REGISTRY:2018-003141-42; OTHER:U1111-1218-5368; NIH:2018

Registered primary outcomes

Number of Participants From Randomization to First Occurrence of a Major Adverse Cardiovascular Event (MACE), a Composite Endpoint Consisting of: Cardiovascular (CV) Death/Non-fatal Myocardial Infarction/Non-fatal Stroke [From randomisation (week 0) up to week 265]

Linked records (15)

Automatic links, confirmed or rejected during screening. A record citing this registration may be a secondary analysis, a commentary or a review that mentions the trial.

Record	Title	Year	Design	Identifiers	Link basis
R0013416	Oral Semaglutide and CV Benefits in the SOUL Trial: How Do Baseline or Changes in HbA1c or BMI Affect Clinical Outcomes? Inzucchi SE, The Journal of clinical endocrinology and metabolism	2026	Randomized trial	PMID 42478869 DOI	cites ClinicalTrials.gov:NCT03914326
R0014491	Oral Semaglutide and Change in Cardiovascular Risk Factors in High-Risk Type 2 Diabetes: A Post Hoc Secondary Analysis of the SOUL Randomized Clinical Trial. Mulvagh SL, JAMA cardiology	2026	Randomized trial	PMID 41879791 DOI	cites ClinicalTrials.gov:NCT03914326; registry reference DERIVED:41879791
R0014773	Oral Semaglutide and Heart Failure Outcomes in Persons With Type 2 Diabetes: A Secondary Analysis of the SOUL Randomized Clinical Trial. Pop-Busui R, JAMA internal medicine	2026	Randomized trial	PMID 41627802 DOI	cites ClinicalTrials.gov:NCT03914326; registry reference DERIVED:41627802
R0015783	Impact of Oral Semaglutide on Kidney Outcomes in People With Type 2 Diabetes: Results From the SOUL Randomized Trial. Mann JFE, Diabetes care	2026	Randomized trial	PMID 41380027 DOI	cites ClinicalTrials.gov:NCT03914326; registry reference DERIVED:41380027
R0018814	Prevalence and Associations of Systemic Inflammation in Heart Failure Across the Spectrum of Ejection Fraction. Borlaug BA, JACC. Heart failure	2026	Other	PMID 41099689 DOI	cites ClinicalTrials.gov:NCT03914326; registry reference DERIVED:41099689
R0006143	Oral Semaglutide and Cardiovascular Outcomes in People With Type 2 Diabetes, According to SGLT2i Use: Prespecified Analyses of the SOUL Randomized Trial. Marx N, Circulation	2025	Randomized trial	PMID 40156843 DOI	cites ClinicalTrials.gov:NCT03914326; registry reference DERIVED:40156843
R0006421	Oral Semaglutide and Cardiovascular Outcomes in High-Risk Type 2 Diabetes. McGuire DK, The New England journal of medicine	2025	Randomized trial	PMID 40162642 DOI	cites ClinicalTrials.gov:NCT03914326; registry reference DERIVED:40162642
R0010237	Glucagon-like peptide 1 (GLP-1) receptor agonists for people with chronic kidney disease and diabetes. Natale P, The Cochrane database of systematic reviews	2025	Systematic review	PMID 39963952 DOI	cites ClinicalTrials.gov:NCT03914326; registry reference DERIVED:39963952
R0041454	Oral Semaglutide and Cardiovascular Outcomes in Persons With Type 2 Diabetes, According to SGLT2i Use: Prespecified Analyses of the SOUL Randomized Trial Steve Bain, Cronfa (Swansea University)	2025	Randomized trial		cites ClinicalTrials.gov:NCT03914326
R0052501	292-OR: Oral Semaglutide and Cardiovascular Outcomes by Baseline A1C and BMI in People with Type 2 Diabetes in the SOUL Trial SILVIO E. INZUCCHI, Diabetes	2025	Randomized trial	DOI	cites ClinicalTrials.gov:NCT03914326
R0007476	Glucagon-like peptide-1 receptor agonists in diabetic kidney disease: A review of their kidney and heart protection. Michos ED, American journal of preventive cardiology	2023	Other trial	PMID 37313358 DOI	cites ClinicalTrials.gov:NCT03914326
R0050208	Prevalence of systemic inflammation in individuals with atherosclerotic cardiovascular disease: baseline characteristics from the SELECT, SOUL and FLOW phase 3 trials of semaglutide Nikolaus Marx, European Heart Journal	2023	Randomized trial	DOI	cites ClinicalTrials.gov:NCT03914326
R0052122	Proportion of patients with systemic inflammation and their characteristics for groups at high cardiovascular risk in phase 3 randomized placebo-controlled trials of semaglutide (SELECT, SOUL, FLOW) John Eric Deanfield, European Heart Journal	2023	Randomized trial	DOI	cites ClinicalTrials.gov:NCT03914326
R0006168	Cardiovascular Safety and Benefits of Semaglutide in Patients With Type 2 Diabetes: Findings From SUSTAIN 6 and PIONEER 6. Nauck MA, Frontiers in endocrinology	2021	Other trial	PMID 33854484 DOI	cites ClinicalTrials.gov:NCT03914326
R0007736	Cardiovascular outcomes, safety, and tolerability with oral semaglutide: insights for managed care. Lingvay I, The American journal of managed care	2020	Other trial	PMID 33439583 DOI	cites ClinicalTrials.gov:NCT03914326