Safety and tolerability of semaglutide across the SUSTAIN and PIONEER phase IIIa clinical trial programmes
Authors' conclusion
The most common AEs with semaglutide were gastrointestinal disorders, which decreased with continued therapy. These comprehensive safety/tolerability data may better inform patient selection and guidance in care.
Study context
- Population
- Patients with T2D in SUSTAIN and PIONEER phase IIIa trials
- Participants
- 11,159 patients16 RCTs
- Comparison
- Subcutaneous or oral semaglutide vs comparators
- Subcutaneous semaglutiden = 3,150
- Oral semaglutiden = 4,116
- Outcome
- Adverse events (AEs) (safety/tolerability)
Methodological details16 phase IIIa trials, placebo- or active-controlled, separate analyses of cardiovascular outcomes trials (CVOTs)
- 16 phase IIIa trials
- Placebo- or active-controlled
- Separate analyses of CVOTs
Pooled result
As reported in the abstract
Gastrointestinal disorders
- Comparators (subcutaneous/oral pools, respectively)
- 22.0%/24.8%
Further pooled results
MACE in CVOTs vs placebo
- Reduced risk of MACE with subcutaneous semaglutide; non-inferiority criteria met with oral semaglutide
- CVOTs n = 6480
Original publication
Safety and tolerability of semaglutide across the SUSTAIN and PIONEER phase IIIa clinical trial programmes. Diabetes Obes Metab. Published 21 February 2023. doi:10.
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