Study S000700

Emulation of the Effects of Oral Semaglutide on Cardiovascular Outcomes in Individuals With Type 2 Diabetes and Established Atherosclerotic Cardiovascular Disease and/or Chronic Kidney Disease: SOUL Trial

ClinicalTrials.gov record Study Protocol and Statistical Analysis Plan (PDF)

Registration

Registration: NCT06659718
Study type: OBSERVATIONAL
Status: COMPLETED
Enrollment: 43650
Start: 2024-10-24
Primary completion: 2025-02-13
Lead sponsor: Brigham and Women's Hospital
Conditions: Diabetes Mellitus, Type 2
Interventions: DRUG:Oral semaglutide; DRUG:Sitagliptin
Results posted: FALSE

Registered primary outcomes

Major adverse cardiac event (MACE), including myocardial infarction, stroke and all cause death [Through study completion (1 day after cohort entry date until the first of outcome or censoring)]

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