Evidence map›Paper›PMID 38985162›Full record

Trial reportDiabetologia2024

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.

Weiqing Wang, Stephen C Bain, Fang Bian, Rui Chen, Sanaz Gabery, Shan Huang, Thomas B Jensen, Bifen Luo, Guoyue Yuan, Guang Ning and 1 more

Registry-linked trialAbstract readRandomized Controlled TrialClinical Trial, Phase IIIMulticenter Study
PubMed Full text at PMC Publisher
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 NCT04109547. Cited by 18 papers, 4 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
18citing papers in PubMed, 4 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.

NCT04109547 phase3completed

China Multi-regional Clinical Trial: Efficacy and Safety of Oral Semaglutide Versus Placebo in Subjects With Type 2 Diabetes Mellitus Treated With Diet and Exercise Only

Ran2019Enrolled521Registered outcomes54Posted comparisons3ConditionsDiabetes Mellitus, Type 2ArmsOral semaglutide, Placebo
Open the trial in the graph
3 · Its place in the literature

Who cites it

18 citing papers in PubMed, 4 syntheses or guidelines pooled it.

  1. Pooled it
  2. Pooled it
  3. Pooled it
  4. Pooled it
  5. Trial
  6. Trial
  7. Bayesian Workflow for Minimal PBPK Models: Case Study of Dapagliflozin.CPT: pharmacometrics & systems pharmacology · 2026
    Article
  8. Article
  9. Article
  10. Review
  11. Observational
  12. Review
  13. Review
  14. The expanding role of semaglutide: beyond glycemic control.Journal of diabetes and metabolic disorders · 2025
    Review
  15. Review
  16. Review
  17. Article
  18. 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

11 authors.

Weiqing WangShanghai Jiaotong University School of Medicine, Shanghai, China.ORCID http://orcid.org/0000-0001-6027-3084
Stephen C BainDiabetes Research Unit, University of Swansea, Swansea, UK. bainsc60@mail.com.ORCID http://orcid.org/0000-0001-8519-4964
Fang BianDepartment of Endocrinology, Cangzhou People's Hospital, Cangzhou, China.ORCID http://orcid.org/0009-0005-1219-4345
Rui ChenNovo Nordisk (China) Pharmaceuticals Co. Ltd., Beijing, China.ORCID http://orcid.org/0009-0007-3128-3524
Sanaz GaberyNovo Nordisk A/S, Søborg, Denmark.ORCID http://orcid.org/0000-0002-2243-7540
Shan HuangEndocrinology Department, Tongren Hospital, Shanghai Jiao Tong University School of Medicine, Shanghai, China.ORCID http://orcid.org/0000-0001-8125-953X
Thomas B JensenNovo Nordisk A/S, Søborg, Denmark.ORCID http://orcid.org/0000-0002-8920-9374
Bifen LuoNovo Nordisk (China) Pharmaceuticals Co. Ltd., Beijing, China.ORCID http://orcid.org/0000-0001-7166-278X
Guoyue YuanAffiliated Hospital of Jiangsu University, Zhenjiang, Jiangsu, China.ORCID http://orcid.org/0000-0003-0822-6066
Guang NingShanghai Jiaotong University School of Medicine, Shanghai, China.ORCID http://orcid.org/0000-0002-5754-7635
PIONEER 11 investigators

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

aims/hypothesisThe aim of this study was to evaluate the efficacy and safety of oral semaglutide monotherapy vs placebo in a predominantly Chinese population with type 2 diabetes insufficiently controlled with diet and exercise alone.

methodsThe Peptide Innovation for Early Diabetes Treatment (PIONEER) 11 trial was a double-blind, randomised, Phase IIIa trial conducted across 52 sites in the China region (mainland China and Taiwan), Hungary, Serbia and Ukraine. Eligible participants were ≥18 years (≥20 years in Taiwan), had a diagnosis of type 2 diabetes with HbA

resultsBetween October 2019 and October 2021, a total of 774 participants were screened and 521 participants were randomised to oral semaglutide 3 mg (n=130), 7 mg (n=130), 14 mg (n=130) or placebo (n=131); most participants (92.5%, n=482) completed the trial, with 39 participants prematurely discontinuing treatment. The number of participants contributing to the trial analyses was based on the total number of participants who were randomised at the beginning of the trial. The majority of participants were male (63.7%), and the mean age of participants was 52 years. At baseline, mean HbA CONCLUSIONS/

interpretationOral semaglutide resulted in significantly greater reductions in HbA

trial registrationClinicalTrials.gov NCT04109547.

fundingNovo Nordisk A/S.

Indexed as

Diabetes Mellitus, Type 2Glucagon-Like Peptide-1 Receptor AgonistsHypoglycemic AgentsAdministration, OralAdultAgedBlood GlucoseChinaDouble-Blind MethodEast Asian PeopleFemaleGlucagon-Like PeptidesGlycated HemoglobinHumansMaleMiddle AgedBlood GlucoseGlucagon-Like Peptide-1 Receptor AgonistsGlucagon-Like PeptidesGlycated HemoglobinHypoglycemic AgentsSemaglutideChinaGLP-1 analogueGlycaemic controlIncretin therapyPhase IIISemaglutideType 2 diabetes

Identifiers

PMID38985162
PMCPMC11410837

What OpenQuestion holds

Texttitle and abstract
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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 OpenQuestion graph.