Evidence map›Paper›PMID 35373893›Full record

ArticleDiabetes, obesity & metabolism2022

Efficacy and safety of oral semaglutide by subgroups of patient characteristics in the PIONEER phase 3 programme.

Vanita R Aroda, Robert Bauer, Erik Christiansen, Martin Haluzík, Klaus Kallenbach, Eduard Montanya, Julio Rosenstock, Juris J Meier

6 registry-linked trialsOpen access · hybridAbstract read
In one paragraph

Article in Diabetes, obesity & metabolism, 2022. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It reports registered trial NCT02607865. Cited by 24 papers.

0numbers the graph read from it
0cells of the map it votes in
24citing papers in PubMed
4.5field-weighted citation impact, top 4% of its field
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.

NCT02607865 phase3completed

Efficacy and Long-term Safety of Oral Semaglutide Versus Sitagliptin in Subjects With Type 2 Diabetes

Ran2016Enrolled1,864Registered outcomes43Posted comparisons24ConditionsDiabetes, Diabetes Mellitus, Type 2ArmsPlacebo, semaglutide, Sitagliptin
PMID 30903796PMID 35064550PMID 34472698other papers from this trial
Open the trial in the graph
NCT02692716 phase3completed

A Trial Investigating the Cardiovascular Safety of Oral Semaglutide in Subjects With Type 2 Diabetes

Ran2017Enrolled3,183Registered outcomes18Posted comparisons13ConditionsDiabetes, Diabetes Mellitus, Type 2ArmsPlacebo, semaglutide
Open the trial in the graph
NCT02849080 phase3completed

Efficacy and Safety of Oral Semaglutide Using a Flexible Dose Adjustment Based on Clinical Evaluation Versus Sitagliptin in Subjects With Type 2 Diabetes Mellitus

Ran2016Enrolled504Registered outcomes69Posted comparisons8ConditionsDiabetes, Diabetes Mellitus, Type 2Armssemaglutide, Sitagliptin
PMID 31189520PMID 33318068other papers from this trial
Open the trial in the graph
NCT02863328 phase3completed

Efficacy and Safety of Oral Semaglutide Versus Empagliflozin in Subjects With Type 2 Diabetes Mellitus

Ran2016Enrolled822Registered outcomes50Posted comparisons8ConditionsDiabetes, Diabetes Mellitus, Type 2Armsempagliflozin, semaglutide
PMID 31530666PMID 35064550other papers from this trial
Open the trial in the graph
NCT02863419 phase3completed

Efficacy and Safety of Oral Semaglutide Versus Liraglutide and Versus Placebo in Subjects With Type 2 Diabetes Mellitus

Ran2016Enrolled711Registered outcomes40Posted comparisons14ConditionsDiabetes, Diabetes Mellitus, Type 2Armsliraglutide, Placebo, semaglutide
PMID 31186120PMID 34472698other papers from this trial
Open the trial in the graph
NCT02906930 phase3completed

Efficacy and Safety of Oral Semaglutide Versus Placebo in Subjects With Type 2 Diabetes Mellitus Treated With Diet and Exercise Only.

Ran2016Enrolled703Registered outcomes48Posted comparisons18ConditionsDiabetes, Diabetes Mellitus, Type 2ArmsPlacebo, semaglutide
Open the trial in the graph
3 · Its place in the literature

Who cites it

24 citing papers in PubMed, 35 citations in OpenAlex.

  1. Trial
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  11. ANMCO statement: semaglutide in the cardio-nephro-metabolic continuum.European heart journal supplements : journal of the European Society of Cardiology · 2025
    Article
  12. Article
  13. Review
  14. Efficacy and Safety of Escalating the Dose of Oral Semaglutide from 7 to 14 mg: A Single-Center, Retrospective Observational Study.Diabetes therapy : research, treatment and education of diabetes and related disorders · 2024
    Article
  15. Review
  16. Review
  17. Review
  18. Review
  19. Article
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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

8 authors at 6 institutions in 5 countries.

Vanita R ArodaBrigham and Women's Hospital, Harvard Medical School, Boston, Massachusetts, USA.ORCID 0000-0002-7706-4585
Robert BauerNovo Nordisk A/S, Søborg, Denmark.
Erik ChristiansenNovo Nordisk A/S, Søborg, Denmark.
Martin HaluzíkDiabetes Centre, Institute for Clinical and Experimental Medicine, Prague, Czech Republic.ORCID 0000-0002-0201-6888
Klaus KallenbachNovo Nordisk A/S, Søborg, Denmark.ORCID 0000-0002-4451-2644
Eduard MontanyaHospital Universitari Bellvitge-IDIBELL, CIBERDEM and University of Barcelona, Barcelona, Spain.ORCID 0000-0003-2518-9076
Julio RosenstockDallas Diabetes Research Center at Medical City, Dallas, Texas, USA.ORCID 0000-0001-8324-3275
Juris J MeierDepartment of Internal Medicine, Gastroenterology and Diabetology, Augusta Clinic, Bochum, Germany.ORCID 0000-0002-5835-8019
Novo Nordisk (Denmark) · DKAugusta-Kranken-Anstalt · DEBellvitge University Hospital · ESBrigham and Women's Hospital · USDallas Diabetes Research Center · USInstitute of Clinical and Experimental Medicine · CZ

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

aimsTo evaluate the efficacy and safety of oral semaglutide versus comparators by patient characteristic subgroups in patients with type 2 diabetes. MATERIALS AND

methodsChange from baseline in glycated haemoglobin (HbA1c) and body weight, and achievement of HbA1c <7.0% with oral semaglutide 7 mg, oral semaglutide 14 mg, flexibly dosed oral semaglutide (flex) and comparators were assessed across baseline subgroups (age, race, ethnicity, diabetes duration, body mass index and HbA1c) from the PIONEER programme. Treatment differences were analysed using a mixed model for repeated measurements for continuous variables and a logistic regression model for the binary endpoint. Pooled safety data were analysed descriptively.

resultsChanges from baseline in HbA1c and body weight, and the odds of achieving HbA1c <7.0%, were greater with oral semaglutide 14 mg/flex (n = 1934) and higher or similar with oral semaglutide 7 mg (n = 823) versus comparators (n = 2077) across most subgroups. Changes in HbA1c with oral semaglutide 14 mg/flex were greater for patients with higher baseline HbA1c (HbA1c >9.0%: -1.7% to -2.6%; HbA1c <8.0%: -0.7% to -1.2%). In some trials, Asian patients experienced greater HbA1c reductions with oral semaglutide 14 mg/flex (-1.5% to -1.8%) than other racial groups (-0.6% to -1.6%). The overall incidence of adverse events (AEs) with oral semaglutide was similar to that with comparators and was consistent across subgroups. More gastrointestinal AEs were observed with oral semaglutide, versus comparators, across subgroups.

conclusionsOral semaglutide demonstrated consistently greater HbA1c and body weight reductions across a range of patient characteristics, with greater HbA1c reductions seen at higher baseline HbA1c levels.

Indexed as

Diabetes Mellitus, Type 2Body WeightGlucagon-Like PeptidesGlycated HemoglobinHumansHypoglycemic AgentsSemaglutideGlucagon-Like PeptidesGlycated HemoglobinHypoglycemic AgentsSemaglutideantidiabetic drugGLP-1 analogueglycaemic controlincretin therapytype 2 diabetesweight control

Identifiers

PMID35373893
PMCPMC9321749
OpenAlexW4224076120

What OpenQuestion holds

Texttitle and abstract
LicenceCC BY-NC
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 OpenQuestion graph.