Efficacy and safety of oral semaglutide vs sitagliptin in a predominantly Chinese population with type 2 diabetes uncontrolled with metformin: PIONEER 12, a double-blind, Phase IIIa, randomised trial
Authors' conclusion
Significantly greater reductions in both HbA1c and body weight over 26 weeks were seen with oral semaglutide 3 mg, 7 mg and 14 mg than with sitagliptin 100 mg in a predominantly Chinese population with type 2 diabetes inadequately controlled with metformin treatment. Oral semaglutide was generally well tolerated, with a safety profile consistent with that seen in the global PIONEER trials.
Study context
- Population
- Adults aged ≥18 years (≥20 years in Taiwan) with T2D, HbA1c 53–91 mmol/mol, on stable daily metformin; China region and five other countries; 75.2% from China regionrandomised
- Participants
- 1,441 adults
- Comparison
- Once-daily oral semaglutide 3 mg, 7 mg or 14 mg vs sitagliptin 100 mg
- Oral semaglutide 3 mgn = 361
- Oral semaglutide 7 mgn = 360
- Oral semaglutide 14 mgn = 361
- Sitagliptin 100 mgn = 359reference
- Primary endpoint
- Change in HbA1c from baseline
- Follow-up
- Week 26
Methodological detailsdouble-dummy, active-controlled, parallel-group, Phase IIIa, double-blind, 90 sites
- Double-dummy
- Active-controlled
- Parallel-group
- Phase IIIa
- Double-blind
- 90 sites
Primary result
As reported in the abstract
Change in HbA1c · baseline to week 26
Each group vs sitagliptin 100 mgETD, mmol/mol (95% CI)
Oral semaglutide 3 mg−0.2 (−0.3, −0.1) percentage points
−2(−4 to −1)
Oral semaglutide 7 mg−0.7 (−0.8, −0.6) percentage points
−8(−9 to −6)
Oral semaglutide 14 mg−1.0 (−1.1, −0.8) percentage points
−11(−12 to −9)
Secondary outcomes
| Outcome | ETD (kg) (95% CI) | |
|---|---|---|
| Change in body weight (confirmatory secondary endpoint) · baseline to week 26Oral semaglutide 3 mgvs Sitagliptin 100 mgSignificantly greater reductions for all doses | −0.9 (−1.4 to −0.4) | |
| Change in body weight (confirmatory secondary endpoint) · baseline to week 26Oral semaglutide 7 mgvs Sitagliptin 100 mgSignificantly greater reductions for all doses | −2.3 (−2.8 to −1.8) | |
| Change in body weight (confirmatory secondary endpoint) · baseline to week 26Oral semaglutide 14 mgvs Sitagliptin 100 mgSignificantly greater reductions for all doses | −3.3 (−3.8 to −2.8) | |
| −4−202Difference, kg (linear scale) |
HbA1c and body weight, China-region subpopulation · baseline to week 26
- Reductions similar to those in the overall population
Safety
Premature treatment discontinuation
- Premature treatment discontinuation — Participants prematurely discontinued treatment
- 130
Adverse events
- Most frequent AEs with semaglutide were gastrointestinal, mostly transient and mild/moderate
- Safety analysis set: 1438 participants
Original publication
Efficacy and safety of oral semaglutide vs sitagliptin in a predominantly Chinese population with type 2 diabetes uncontrolled with metformin: PIONEER 12, a double-blind, Phase IIIa, randomised trial. Diabetologia. Published 10 July 2024. doi:10.
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