Real-World Data Study Emulates SOUL Trial for Oral Semaglutide Outcomes
Emulation of the SOUL Diabetes Trial in Healthcare Claims
Background
Type 2 Diabetes (T2D) patients with atherosclerotic cardiovascular disease (ASCVD) or chronic kidney disease (CKD) face significant cardiovascular risks. GLP-1 receptor agonists (GLP-1 RAs) like semaglutide have shown promise in reducing these risks in randomized controlled trials (RCTs). This study aims to evaluate if real-world healthcare claims data can accurately emulate the cardiovascular and renal outcomes observed in such rigorous clinical trials.
Study Design
Population
Type 2 Diabetes (T2D) patients with atherosclerotic cardiovascular disease (ASCVD) or chronic kidney disease (CKD) as studied in the SOUL Diabetes Trial.
Intervention
Oral semaglutide, with dose, route, and duration as per the SOUL Diabetes Trial protocol.
Comparator
Placebo, as per the SOUL Diabetes Trial protocol.
Outcome
Cardiovascular and renal outcomes, as measured in the SOUL Diabetes Trial.
