Using real-world data to predict findings of an ongoing phase IV trial: glycemic control of semaglutide versus standard of care
Main finding · HbA1c <7%Result — go to the resultRelative risk 1.30 95% CI 1.16–1.45Authors' conclusion
This claims database study, designed to predict the results of the SEPRA trial, found results consistent with interim trial results. Our findings support the notion that well-designed non-randomized studies using fit-for-purpose data can effectively complement pragmatic randomized controlled trials.
Study context
- Population
- Adults with T2D on metformin monotherapy with recorded HbA1c, meeting eligibility criteria adapted from the SEPRA trial; Optum Clinformatics, July 2017 - May 20221,144 propensity score-matched (PSM) pairs
- Exposure
- Once-weekly injectable semaglutide vs SoC medications
- Outcome
- Proportion of patients achieving HbA1c <7%
Methodological detailstarget trial emulation of the SEPRA trial, 1:1 propensity-score matched, claims database (Optum Clinformatics), preregistered protocol, Results consistent with interim results of the SEPRA trial, released after the protocol was preregistered
- Target trial emulation of the SEPRA trial
- 1:1 propensity-score matched
- Claims database (Optum Clinformatics)
- Preregistered protocol
- Results consistent with interim results of the SEPRA trial, released after the protocol was preregistered
Main finding
HbA1c <7%
Relative risk
1.30
95% CI 1.16–1.45
Semaglutidevs SoC
RR 1.30 (95% CI 1.16–1.45)
As reported in the abstract
Observational data: associations, not effects.
Further findings
Reduction in HbA1c
Parts of this Brief are withheld: the automatic checks could not confirm them against the abstract.
Original publication
Using real-world data to predict findings of an ongoing phase IV trial: glycemic control of semaglutide versus standard of care. BMJ Open Diabetes Res Care. Published 29 October 2025. doi:10.
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