Efficacy and safety of once-daily oral semaglutide 25 mg and 50 mg compared with 14 mg in adults with type 2 diabetes (PIONEER PLUS): a multicentre, randomised, phase 3b trial
Authors' conclusion
Oral semaglutide 25 mg and 50 mg were superior to 14 mg in reducing HbA1c and bodyweight in adults with inadequately controlled type 2 diabetes. No new safety concerns were identified.
Study context
- Population
- Adults with T2D, HbA1c 8.0–10.5% (64–91 mmol/mol), BMI ≥25.0 kg/m², on stable 1–3 oral glucose-lowering drugs; 177 sites in 14 countriesrandomized 1:1:1
- Participants
- 1,606 adults
- Comparison
- Oral semaglutide 25 mg and 50 mg vs 14 mg once daily
- 14 mgn = 536reference
- 25 mgn = 535
- 50 mgn = 535
- Primary endpoint
- Change in HbA1c from baseline (treatment policy estimand, ITT population)
- Follow-up
- Week 52
Methodological detailsglobal, multicentre, double-blind, phase 3b
- Global
- Multicentre
- Double-blind
- Phase 3b
Primary result
As reported in the abstract
Change in HbA1c
14 mg
−1.5
mean · SE 0.05 · percentage points
25 mg
−1.8
mean · SE 0.06 · percentage points
50 mg
−2.0
mean · SE 0.06 · percentage points
Each group vs 14 mgEstimated treatment difference (95% CI)P value
25 mg
−0.27(−0.42 to −0.12)
P = 0.000650 mg
−0.53(−0.68 to −0.38)
P < 0.0001Further findings
- Deaths during the trial; none judged treatment related
- 10
Safety
Adverse events
Gastrointestinal disorders
- Mostly mild to moderate; more frequent with 25 mg and 50 mg than with 14 mg
Original publication
Efficacy and safety of once-daily oral semaglutide 25 mg and 50 mg compared with 14 mg in adults with type 2 diabetes (PIONEER PLUS): a multicentre, randomised, phase 3b trial. Lancet. Published 26 June 2023. doi:10.
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