Study S000545

Long Term Comparative Effectiveness of Once Weekly Semaglutide Versus Standard of Care in a Real World Adult US Population With Type 2 Diabetes - a Randomized Pragmatic Clinical Trial

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

Registration

Registration: NCT03596450
Study type: INTERVENTIONAL
Allocation: RANDOMIZED
Phase: PHASE4
Masking: NONE
Status: COMPLETED
Enrollment: 1278
Start: 2018-07-13
Primary completion: 2022-06-09
Lead sponsor: Novo Nordisk A/S
Conditions: Diabetes Mellitus, Type 2
Interventions: DRUG:Semaglutide; DRUG:Standard of care
Results posted: TRUE
Individual participant data sharing: YES
Secondary identifiers: OTHER:U1111-1207-6474

Registered primary outcomes

Number of Participants With Glycosylated Haemoglobin (HbA1c) Less Than 7.0 Percentage (%) (53 Millimoles Per Mole [mmol/Mol]) at Year 1 (Yes/No) [At year 1]

Linked records (6)

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
R0015592	Long-term comparative effectiveness of once-weekly semaglutide versus alternative treatments in a real-world US adult population with type 2 diabetes: a randomized pragmatic clinical trial. Buse JB, BMJ open diabetes research & care	2025	Randomized trial	PMID 41093600 DOI	cites ClinicalTrials.gov:NCT03596450; registry reference DERIVED:41093600
R0037287	230-OR: Comparative Effectiveness of Semaglutide in Type 2 Diabetes—Year 2 Results of a Randomized Pragmatic Clinical Trial John B. Buse, Diabetes	2024	Randomized trial	DOI	cites ClinicalTrials.gov:NCT03596450
R0049939	Study design and baseline profile for adults with type 2 diabetes in the once-weekly subcutaneous SEmaglutide randomized PRAgmatic (SEPRA) trial MJ Cziraky, Carolina Digital Repository (University of North Carolina at Chapel Hill)	2024	Protocol	DOI	cites ClinicalTrials.gov:NCT03596450
R0016000	Study design and baseline profile for adults with type 2 diabetes in the once-weekly subcutaneous SEmaglutide randomized PRAgmatic (SEPRA) trial. Buse JB, BMJ open diabetes research & care	2023	Protocol	PMID 37137527 DOI	cites ClinicalTrials.gov:NCT03596450; registry reference DERIVED:37137527
R0038398	776-P: Comparative Effectiveness of SC Semaglutide in Adults with T2D in U.S. Routine Clinical Practice—Year 1 Results of SEPRA, a Randomized Pragmatic Clinical Trial John B. Buse, Diabetes	2023	Randomized trial	DOI	cites ClinicalTrials.gov:NCT03596450
R0038308	752-P: Study Design and Baseline Profile for Patients with Type 2 Diabetes in the Semaglutide Once-Weekly Randomized Pragmatic Trial (SEPRA) Vincent J. Willey, Diabetes	2022	Protocol	DOI	cites ClinicalTrials.gov:NCT03596450