Efficacy and safety of oral semaglutide monotherapy vs placebo in a predominantly Chinese population with type 2 diabetes (PIONEER 11): a double-blind, Phase IIIa, randomised trial
Authors' conclusion
Oral semaglutide resulted in significantly greater reductions in HbA1c across all doses and in significant body weight reductions for the 7 mg and 14 mg doses when compared with placebo in predominantly Chinese participants with type 2 diabetes insufficiently controlled by diet and exercise alone. Oral semaglutide was generally well tolerated, with a safety profile consistent with that seen in the global PIONEER trials.
Study context
- Population
- Adults ≥18 years (≥20 in Taiwan) with T2D, HbA1c 53–86 mmol/mol (7.0–10.0%), insufficiently controlled with diet and exercise, no glucose-lowering drugs; China region, Hungary, Serbia, Ukraine; 63.7% male, mean age 52 years482 completed
- Participants
- 521 adults
- Comparison
- Once-daily oral semaglutide 3 mg, 7 mg or 14 mg vs placebo
- Oral semaglutide 3 mgn = 130
- Oral semaglutide 7 mgn = 130
- Oral semaglutide 14 mgn = 130
- Placebon = 131reference
- Primary endpoint
- Change from baseline in HbA1c
- Follow-up
- Week 26
Methodological detailsdouble-blind, placebo-controlled, Phase IIIa, multicentre (52 sites), stratified by China region vs elsewhere, 4-week run-in with diet and exercise alone, Randomised 1:1:1:1 via web-based system
- Double-blind
- Placebo-controlled
- Phase IIIa
- Multicentre (52 sites)
- Stratified by China region vs elsewhere
- 4-week run-in with diet and exercise alone
- Randomised 1:1:1:1 via web-based system
Primary result
As reported in the abstract
Change in HbA1c
Each group vs placeboETD, mmol/mol (95% CI)P value
Oral semaglutide 3 mg
−11(−13 to −9)
P < 0.001 for all dosesOral semaglutide 7 mg
−16(−18 to −13)
P < 0.001 for all dosesOral semaglutide 14 mg
−17(−19 to −15)
P < 0.001 for all dosesEach group vs placeboETD, percentage points (95% CI)
Oral semaglutide 3 mg
−1.0(−1.2 to −0.8)
Oral semaglutide 7 mg
−1.4(−1.6 to −1.2)
Oral semaglutide 14 mg
−1.5(−1.8 to −1.3)
Secondary outcomes
| Outcome | ETD (kg) (95% CI) | P value | |
|---|---|---|---|
| Change in body weight (confirmatory secondary endpoint) · week 26Oral semaglutide 3 mgvs Placebo | −0.0 (−0.9 kg, 0.8 kg) | not significant | |
| Change in body weight (confirmatory secondary endpoint) · week 26Oral semaglutide 7 mgvs Placebo | −1.2 (−2.0 kg, −0.4 kg) | P < 0.01 | |
| Change in body weight (confirmatory secondary endpoint) · week 26Oral semaglutide 14 mgvs Placebo | −2.0 (−2.8 kg, −1.2 kg) | P < 0.001 | |
| −4−202Difference, kg (linear scale) |
HbA1c and body weight, Chinese subpopulation (74.9% of participants) · week 26
- Similar reductions in HbA1c and body weight in the Chinese subpopulation
Safety
- Adverse events (AEs) — Placebo
- 57.3%
- AEs — AEs with oral semaglutide (all doses)
- between 65.4% and 72.3%
AEs
- Most AEs mild to moderate; few serious AEs
- Most common AEs gastrointestinal, more frequent with semaglutide (all doses) than placebo
- Proportion of AEs slightly higher in the Chinese subpopulation
Original publication
Efficacy and safety of oral semaglutide monotherapy vs placebo in a predominantly Chinese population with type 2 diabetes (PIONEER 11): a double-blind, Phase IIIa, randomised trial. Diabetologia. Published 10 July 2024. doi:10.
Composed by AI from the published abstract and checked against it. How Briefs are made →