Study design and baseline profile for adults with type 2 diabetes in the once-weekly subcutaneous SEmaglutide randomized PRAgmatic (SEmaglutide PRAgmatic (SEPRA)) trial
Authors' conclusion
SEPRA, a highly pragmatic ongoing study, will provide data on the effects of once-weekly subcutaneous semaglutide in a real-world setting when used during routine management of T2D.
Study context
- Population
- US health-insured adults with T2D and physician-determined inadequate glycemic control; 138 US sitesenrolled
- Participants
- 1,278 adults
- Comparison
- Once-weekly subcutaneous semaglutide vs standard of care
- Primary endpoint
- Proportion of participants achieving HbA1c <7.0%
- Follow-up
- Year 1
Methodological detailsongoing, open-label, randomized, multicentre, Enrolment July 2018 to March 2021; last patient last visit expected by June 2023
- Ongoing
- Open-label
- Randomized
- Multicentre
- Enrolment July 2018 to March 2021; last patient last visit expected by June 2023
Primary result
As reported in the abstract
Baseline characteristics
- Male
- 54%
- Age, mean±SD
- 57.4±11.1 years
- BMI, mean±SD
- 35.7±8.0 kg/m²
- Diabetes duration, mean±SD
- 7.4±6.0 years
- HbA1c, mean±SD
- 8.5±1.6%
- PRECIS-2 score in all domains (highly pragmatic)
- 4-5
Original publication
Study design and baseline profile for adults with type 2 diabetes in the once-weekly subcutaneous SEmaglutide randomized PRAgmatic (SEPRA) trial. BMJ Open Diabetes Res Care. Published 3 May 2023. doi:10.
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