Pooled analysis of 3,505 adults with T2D from nine SURE real-world studies confirmed once-weekly semaglutide is well-tolerated, with 24.3% reporting adverse events (mostly mild GI), 0.5% serious drug reactions, and safety consistent with phase 3 RCT data.
3,505 patients, 9 countriesThe largest pooled real-world safety analysis of once-weekly semaglutide confirms safety is consistent with clinical trial data
What the researchers found
Among 3,505 T2D patients in real-world practice, once-weekly semaglutide showed 24.3% AE rate (mostly mild GI), 5.1% discontinuation rate, 0.5% serious ADRs, and 0.1% severe hypoglycemia — consistent with phase 3 RCT safety data.
Why it matters
Real-world safety data is essential because clinical trial participants are carefully selected and monitored. Confirming semaglutide's safety across 3,505 unselected patients in routine practice gives prescribers and patients confidence that the drug is safe outside controlled settings.
The numbers in context
9 SURE studies pooled. ~30-week duration each. Multiple subpopulations analyzed including elderly, obese, and renal impairment.
How the study worked
Post hoc pooled analysis of nine SURE programme real-world studies (~30 weeks each). Collected safety data including AEs, serious AEs, hypoglycemic events, and treatment discontinuations. Analyzed for total population and subgroups based on baseline characteristics, co-medications, and prescriber specialty.
Who was studied
Adults with T2D in routine clinical practice across 9 countries
What this study cannot tell us
Observational studies lack the rigor of randomized trials. About 30 weeks of follow-up may miss longer-term safety signals. Subgroup analyses are hypothesis-generating, not definitive. Voluntary adverse event reporting may lead to underreporting.
How to read the evidence
Strong evidence from a large pooled analysis of nine real-world studies. While observational in design, the sample size and multi-country scope provide robust safety characterization.
When this study was published
Published in 2024; represents the most comprehensive real-world safety analysis of once-weekly semaglutide available.
The bigger picture
As GLP-1 agonists are prescribed to millions of people globally, large-scale real-world safety surveillance becomes increasingly important. The SURE programme provides the most comprehensive real-world safety dataset for once-weekly semaglutide, complementing the controlled environment of the SUSTAIN clinical trials.
Questions still open
- Do safety profiles differ when semaglutide is used at the higher 2.4 mg dose for weight loss versus the 0.5-1.0 mg diabetes dose?
- What are the long-term (>2 year) real-world safety outcomes?
- How does the real-world safety profile compare between once-weekly injectable and oral semaglutide formulations?
Common questions
Is once-weekly semaglutide safe in real-world use?
How often do people stop taking semaglutide due to side effects?
Read the original research
Real-world safety profile of once-weekly semaglutide in people with type 2 diabetes: Analysis of pooled data from the SemaglUtide Real-world Evidence (SURE) programme.
Diabetes, obesity & metabolism, 26(10), 4429-4440
Citation
Yale, Jean-François; Major-Pedersen, Atheline; Catarig, Andrei-Mircea; Jain, Rashmi; Menzen, Markus; Holmes, Patrick. (2024). Real-world safety profile of once-weekly semaglutide in people with type 2 diabetes: Analysis of pooled data from the SemaglUtide Real-world Evidence (SURE) programme.. Diabetes, obesity & metabolism, 26(10), 4429-4440. https://doi.org/10.1111/dom.15794