Evidence mapPaperPMID 38985161Full record

Trial reportDiabetologia2024

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.

Linong Ji, Rikke M Agesen, Stephen C Bain, Fangming Fu, Sanaz Gabery, Jianlin Geng, Yiming Li, Yibing Lu, Bifen Luo, Wuyan Pang and 2 more

Registry-linked trialAbstract readClinical Trial, Phase IIIMulticenter StudyRandomized Controlled Trial
In one paragraph

Trial report in Diabetologia, 2024. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It reports registered trial NCT04017832. Cited by 12 papers, 3 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
12citing papers in PubMed, 3 pooled it
field-weighted citation impact
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

NCT04017832 phase3completed

China Multi-regional Clinical Trial: Efficacy and Safety of Oral Semaglutide Versus Sitagliptin in Subjects With Type 2 Diabetes Mellitus Treated With Metformin

Ran2019Enrolled1,441Registered outcomes44Posted comparisons3ConditionsDiabetes Mellitus, Type 2ArmsOral semaglutide, Placebo (oral semaglutide), Placebo (sitagliptin), Sitagliptin
Open the trial in the graph
3 · Its place in the literature

Who cites it

12 citing papers in PubMed, 3 syntheses or guidelines pooled it.

  1. Pooled it
  2. Pooled it
  3. Pooled it
  4. Trial
  5. Article
  6. Article
  7. Review
  8. Review
  9. The expanding role of semaglutide: beyond glycemic control.Journal of diabetes and metabolic disorders · 2025
    Review
  10. Review
  11. Article
  12. A Bioequivalence Study of Two Formulations of Oral Semaglutide in Healthy Participants.Diabetes therapy : research, treatment and education of diabetes and related disorders · 2025
    Article
4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

12 authors.

Linong JiPeking University People's Hospital, Beijing, China.ORCID http://orcid.org/0000-0002-3262-2168
Rikke M AgesenNovo Nordisk A/S, Søborg, Denmark.ORCID http://orcid.org/0000-0002-7649-7928
Stephen C BainDiabetes Research Unit, Swansea University, Swansea, UK. bainsc60@mail.com.ORCID http://orcid.org/0000-0001-8519-4964
Fangming FuJinan Central Hospital Affiliated to Shandong First Medical University, Jinan, China.ORCID http://orcid.org/0000-0002-0874-7526
Sanaz GaberyNovo Nordisk A/S, Søborg, Denmark.ORCID http://orcid.org/0000-0002-2243-7540
Jianlin GengHarrison International Peace Hospital, Hengshui, China.ORCID http://orcid.org/0009-0001-6844-9221
Yiming LiHuashan Hospital, Fudan University, Shanghai, China.ORCID http://orcid.org/0000-0002-1828-8765
Yibing LuSecond Affiliated Hospital of Nanjing Medical University, Nanjing, China.
Bifen LuoNovo Nordisk (China) Pharmaceuticals Co., Ltd., Beijing, China.ORCID http://orcid.org/0000-0001-7166-278X
Wuyan PangHuaihe Hospital of Henan University, Kaifeng, Henan, China.
Yi TaoNovo Nordisk (China) Pharmaceuticals Co., Ltd., Beijing, China.ORCID http://orcid.org/0009-0003-6453-5354
PIONEER 12 investigators

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

aims/hypothesisThe aim of this study was to assess the efficacy and safety of oral semaglutide vs sitagliptin in a predominantly Chinese population with type 2 diabetes inadequately controlled with metformin treatment.

methodsThe Peptide Innovation for Early Diabetes Treatment (PIONEER) 12 trial was a randomised, double-dummy, active-controlled, parallel-group, Phase IIIa trial conducted over 26 weeks at 90 sites across the China region (including mainland China, Taiwan and Hong Kong) and five other countries. Adults aged ≥18 years (≥20 years in Taiwan) with a diagnosis of type 2 diabetes, HbA

resultsOf 1839 participants screened, 1441 were randomly assigned to oral semaglutide 3 mg (n=361), 7 mg (n=360), 14 mg (n=361) or sitagliptin 100 mg (n=359) and included in the FAS. A total of 1438 participants were included in the SAS. In total, 75.2% of participants were from the China region. A total of 1372 (95.2%) participants completed the trial and 130 participants prematurely discontinued treatment (8.3%, 8.6% and 15.0% for oral semaglutide 3 mg, 7 mg and 14 mg, respectively; 4.2% for sitagliptin 100 mg). Significantly greater reductions in HbA CONCLUSIONS/

interpretationSignificantly greater reductions in both HbA

trial registrationClinicalTrials.gov NCT04017832.

fundingThis trial was funded by Novo Nordisk A/S, Søborg, Denmark.

Indexed as

Diabetes Mellitus, Type 2Glucagon-Like PeptidesHypoglycemic AgentsMetforminSitagliptin PhosphateAdministration, OralAdultAgedBlood GlucoseChinaDouble-Blind MethodEast Asian PeopleFemaleGlycated HemoglobinHumansMaleBlood GlucoseGlucagon-Like PeptidesGlycated HemoglobinHypoglycemic AgentsMetforminSemaglutideSitagliptin PhosphateTriazolesGLP-1 analogueGlycaemic controlIncretin therapyPhase IIISemaglutideType 2 diabetes

Identifiers

PMID38985161
PMCPMC11410852

What Socratic holds

Texttitle and abstract
LicenceCC BY
Read underepoch 390

Registered trials

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the Socratic graph.