Effects of oral semaglutide on cardiovascular outcomes in individuals with type 2 diabetes and established atherosclerotic cardiovascular disease and/or chronic kidney disease: Design and baseline characteristics of SOUL , a randomized trial
Authors' conclusion
SOUL will provide evidence regarding the CV effects of oral semaglutide in individuals with type 2 diabetes and established ASCVD and/or CKD.
Study context
- Population
- Individuals aged ≥50 years with T2D and established atherosclerotic CV disease (ASCVD) (CAD, cerebrovascular disease, symptomatic PAD) and/or chronic kidney disease (CKD) (eGFR <60 mL/min/1.73 m²)enrolled
- Participants
- 9,650 individuals
- Comparison
- Oral semaglutide 14 mg once daily vs placebo, both added to standard of care
- Primary endpoint
- Time from randomisation to first major adverse CV event (MACE) (cardiovascular (CV) death, nonfatal MI or nonfatal stroke); trial continues until 1225 first adjudication-confirmed MACEs
Methodological detailsdouble-blind, parallel-group, placebo-controlled, event-driven, Enrolment June 17, 2019 to March 24, 2021; enrolment completed
- Double-blind
- Parallel-group
- Placebo-controlled
- Event-driven
- Enrolment June 17, 2019 to March 24, 2021; enrolment completed
Primary result
As reported in the abstract
Baseline characteristics
- Men
- 71.1%
- White ethnicity
- 68.9%
- Mean age
- 66.1 years
- Diabetes duration
- 15.4 years
- BMI
- 31.1 kg/m²
- HbA1c
- 63.5 mmol/mol [8.0%]
- Metformin
- 75.7%
- Insulin and insulin analogues
- 50.5%
- SU
- 29.1%
- SGLT2i
- 26.7%
- DPP-4i
- 23.0%
- CAD
- 70.7%
- CKD
- 42.3%
- Cerebrovascular disease
- 21.1%
- Symptomatic PAD
- 15.7%
- Prevalent HF
- 23.0%
Original publication
Effects of oral semaglutide on cardiovascular outcomes in individuals with type 2 diabetes and established atherosclerotic cardiovascular disease and/or chronic kidney disease: Design and baseline characteristics of SOUL , a randomized trial. Diabetes Obes Metab. Published 11 April 2023. doi:10.
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