A Retrospective Database Study to Compare Cardiovascular and Renal Outcomes of Ozempic® (OW Semaglutide) Versus Other Anti-Diabetic Drugs in Chinese T2D Patients

Registration

Registration

NCT07456774

Acronym

SPOTLIGHT

Study type

OBSERVATIONAL

Status

ENROLLING_BY_INVITATION

Enrollment

100000

Start

2026-02-13

Primary completion

2026-08-31

Lead sponsor

Novo Nordisk A/S

Conditions

Type 2 Diabetes

Results posted

FALSE

Individual participant data sharing

YES

Registered primary outcomes

• Time to 3P major adverse cardiovascular events [From index date to the first composite 3P MACE (stroke, myocardial infarction, all-cause death) event or censoring event (up to 36 months)]
• Time to 5P MACE [From index date to the first composite 5P MACE (stroke, myocardial infarction, all-cause death, heart failure hospitalization, coronary revascularization) event or censoring event (up to 36 months)]
• Time to stroke [From index date to the first stroke event or censoring event (up to 36 months)]
• Time to myocardial infarction (MI) [From index date to the first MI event or censoring event (up to 36 months)]
• Time to heart failure (HF) [From index date to the first HF event or censoring event (up to 36 months)]
• Time to composite renal event [From index date to first composite renal (kidney failure: dialysis/transplantation/eGFR <15, ≥50% eGFR reduction from baseline, or kidney-related/cardiovascular death) or censoring event (up to 36 months)]
• Time to renal disease-related hospitalization [From index date to the first renal disease-related hospitalization or censoring event (up to 36 months)]
• Incidence rate of 3P MACE [From index date to the first composite 3P MACE (stroke, myocardial infarction, all-cause death) event or censoring event (up to 36 months)]
• Incidence rate of 5P MACE [From index date to the first composite 5P MACE (stroke, myocardial infarction, all-cause death, heart failure hospitalization, coronary revascularization) event or censoring event (up to 36 months)]
• Incidence rate of stroke [From index date to the first stroke event or censoring event (up to 36 months)]
• Incidence rate of myocardial infarction [From index date to the first MI event or censoring event (up to 36 months)]
• Incidence rate of heart failure [From index date to the first HF event or censoring event (up to 36 months)]
• Incidence rate of composite renal event [From index date to first composite renal (kidney failure: dialysis/transplantation/eGFR <15, ≥50% eGFR reduction from baseline, or kidney-related/cardiovascular death) or censoring event (up to 36 months)]
• Incidence rate of renal disease-related hospitalization [From index date to the first renal disease-related hospitalization or censoring event (up to 36 months)]