Skip to content

Study · Randomized controlled trial · n = 1,606 · 2023

8 results

Efficacy and safety of once-daily oral semaglutide 25 mg and 50 mg compared with 14 mg in adults with type 2 diabetes (PIONEER PLUS): a multicentre, randomised, phase 3b trial.

Aroda VR, Aberle J, Bardtrum L, Christiansen E, Knop FK, Gabery S, Pedersen SD, Buse JB

Lancet (London, England)26 Jun 2023Cited by 83 (Europe PMC)

PMID37385279 (opens in a new tab)DOI10.1016/s0140-6736(23)01127-3 (opens in a new tab)PepBankPUB-37385279
Source linkPubMedAsk about this study
Jump to 8 results

Summary

The text of this summary is not shown here, because the article license does not allow reuse. Read it at the source (opens in a new tab)

Text rights: Publisher copyright. Results still quote short attributed sentences.

Results from this study8

8 results from studies that gave the peptide. 8 results from people.

  1. 01HumanRandomized controlled trialEfficacy outcome

    In adults with type 2 diabetes, oral semaglutide 14 mg lowered HbA1c by 1.5 percentage points at week 52.

    In plain wordsIn adults with type 2 diabetes, oral semaglutide 14 mg lowered HbA1c, a measure of blood sugar control.

    Peptide
    Semaglutide
    Outcome
    DecreaseHbA1c change at week 52
    Study

    n = 536

    Analysis
    Primary
    Outcome group
    Glycemic control · Metabolic and weight
    Studied dose
    14 mg once daily · oral · 68 weeksAs given in this study (human).

    Measurements

    HbA1c change
    −1.5 percentage points
    oral semaglutide 14 mg

    Source sentences

    Summary
    Mean changes (SE) in HbA1c at week 52 were -1·5 percentage points (SE 0·05) with oral semaglutide 14 mg
    1 context sentence
    Summary · context
    This global, multicentre, randomised, double-blind, phase 3b trial, carried out at 177 sites in 14 countries, enrolled adults with type 2 diabetes, glycated haemoglobin (HbA1c) 8·0-10·5% (64-91 mmol/mol), a BMI of 25·0 kg/m2 or greater, receiving stable daily doses of one to th…
  2. 02HumanRandomized controlled trialEfficacy outcome

    In adults with type 2 diabetes, oral semaglutide 25 mg lowered HbA1c by 1.8 percentage points at week 52, 0.27 more than 14 mg.

    In plain wordsIn adults with type 2 diabetes, oral semaglutide 25 mg lowered HbA1c more than the approved 14 mg dose.

    Peptide
    Semaglutide
    Outcome
    DecreaseHbA1c change at week 52
    Study

    n = 535

    Comparator
    Oral semaglutide 14 mg
    Analysis
    Primary
    Outcome group
    Glycemic control · Metabolic and weight
    Studied dose
    25 mg once daily · oral · 68 weeksAs given in this study (human).

    Measurements

    HbA1c change
    −1.8 percentage points
    oral semaglutide 25 mg
    Estimated treatment difference
    −0.27 percentage points
    25 mg vs 14 mg

    Source sentences

    Summary
    -1·8 percentage points (0·06) with 25 mg (estimated treatment difference [ETD] -0·27, 95% CI -0·42 to -0·12; p=0·0006)
    1 context sentence
    Summary · context
    This global, multicentre, randomised, double-blind, phase 3b trial, carried out at 177 sites in 14 countries, enrolled adults with type 2 diabetes, glycated haemoglobin (HbA1c) 8·0-10·5% (64-91 mmol/mol), a BMI of 25·0 kg/m2 or greater, receiving stable daily doses of one to th…
  3. 03HumanRandomized controlled trialEfficacy outcome

    In adults with type 2 diabetes, oral semaglutide 50 mg lowered HbA1c by 2.0 percentage points at week 52, 0.53 more than 14 mg.

    In plain wordsIn adults with type 2 diabetes, oral semaglutide 50 mg lowered HbA1c more than the approved 14 mg dose.

    Peptide
    Semaglutide
    Outcome
    DecreaseHbA1c change at week 52
    Study

    n = 535

    Comparator
    Oral semaglutide 14 mg
    Analysis
    Primary
    Outcome group
    Glycemic control · Metabolic and weight
    Studied dose
    50 mg once daily · oral · 68 weeksAs given in this study (human).

    Measurements

    HbA1c change
    −2 percentage points
    oral semaglutide 50 mg
    Estimated treatment difference
    −0.53 percentage points
    50 mg vs 14 mg

    Source sentences

    Summary
    and -2·0 percentage points (0·06) with 50 mg (ETD -0·53, -0·68 to -0·38; p<0·0001)
    1 context sentence
    Summary · context
    This global, multicentre, randomised, double-blind, phase 3b trial, carried out at 177 sites in 14 countries, enrolled adults with type 2 diabetes, glycated haemoglobin (HbA1c) 8·0-10·5% (64-91 mmol/mol), a BMI of 25·0 kg/m2 or greater, receiving stable daily doses of one to th…
  4. 04HumanRandomized controlled trialSafety outcome

    In adults with type 2 diabetes, gastrointestinal disorders, mostly mild to moderate, occurred more often with oral semaglutide 25 mg and 50 mg than with 14 mg.

    In plain wordsIn adults with type 2 diabetes, gut side effects were more common with the 25 mg and 50 mg doses than with 14 mg.

    Peptide
    Semaglutide
    Outcome
    IncreaseGastrointestinal disorders
    Study

    n = 1,606

    Comparator
    Oral semaglutide 14 mg
    Outcome group
    Gastrointestinal adverse events · Gastrointestinal
    Studied dose
    25 mg and 50 mg once daily · oral · 68 weeksAs given in this study (human).

    Source sentences

    Summary
    Gastrointestinal disorders, which were mostly mild to moderate, occurred more frequently with oral semaglutide 25 mg and 50 mg than with 14 mg.
    1 context sentence
    Summary · context
    This global, multicentre, randomised, double-blind, phase 3b trial, carried out at 177 sites in 14 countries, enrolled adults with type 2 diabetes, glycated haemoglobin (HbA1c) 8·0-10·5% (64-91 mmol/mol), a BMI of 25·0 kg/m2 or greater, receiving stable daily doses of one to th…
  5. 05HumanRandomized controlled trialSafety outcome

    In adults with type 2 diabetes, ten deaths occurred during the trial across the oral semaglutide dose groups and none were judged to be treatment related.

    In plain wordsIn adults with type 2 diabetes, ten people died during the trial; none of the deaths were judged to be caused by the treatment.

    Peptide
    Semaglutide
    Outcome
    Not applicableDeaths during the trial
    Study

    n = 1,606

    Outcome group
    Mortality · Whole body
    Studied dose
    14 mg, 25 mg or 50 mg once daily · oral · 68 weeksAs given in this study (human).

    Source sentences

    Summary
    Ten deaths occurred during the trial; none were judged to be treatment related.
    1 context sentence
    Summary · context
    This global, multicentre, randomised, double-blind, phase 3b trial, carried out at 177 sites in 14 countries, enrolled adults with type 2 diabetes, glycated haemoglobin (HbA1c) 8·0-10·5% (64-91 mmol/mol), a BMI of 25·0 kg/m2 or greater, receiving stable daily doses of one to th…
  6. 06HumanRandomized controlled trialSafety outcome

    In adults with type 2 diabetes, 76% of participants had adverse events with oral semaglutide 14 mg.

    In plain wordsIn adults with type 2 diabetes, about three in four people on oral semaglutide 14 mg had a side effect.

    Peptide
    Semaglutide
    Outcome
    Not applicableAdverse events (any)
    Study

    n = 536

    Outcome group
    Adverse events · Whole body
    Studied dose
    14 mg once daily · oral · 68 weeksAs given in this study (human).

    Measurements

    Participants with adverse events
    76%
    oral semaglutide 14 mg

    Source sentences

    Summary
    Adverse events were reported by 404 (76%) participants in the oral semaglutide 14 mg group
    1 context sentence
    Summary · context
    This global, multicentre, randomised, double-blind, phase 3b trial, carried out at 177 sites in 14 countries, enrolled adults with type 2 diabetes, glycated haemoglobin (HbA1c) 8·0-10·5% (64-91 mmol/mol), a BMI of 25·0 kg/m2 or greater, receiving stable daily doses of one to th…
  7. 07HumanRandomized controlled trialSafety outcome

    In adults with type 2 diabetes, 79% of participants had adverse events with oral semaglutide 25 mg.

    In plain wordsIn adults with type 2 diabetes, about four in five people on oral semaglutide 25 mg had a side effect.

    Peptide
    Semaglutide
    Outcome
    Not applicableAdverse events (any)
    Study

    n = 535

    Outcome group
    Adverse events · Whole body
    Studied dose
    25 mg once daily · oral · 68 weeksAs given in this study (human).

    Measurements

    Participants with adverse events
    79%
    oral semaglutide 25 mg

    Source sentences

    Summary
    422 (79%) in the 25 mg group
    1 context sentence
    Summary · context
    This global, multicentre, randomised, double-blind, phase 3b trial, carried out at 177 sites in 14 countries, enrolled adults with type 2 diabetes, glycated haemoglobin (HbA1c) 8·0-10·5% (64-91 mmol/mol), a BMI of 25·0 kg/m2 or greater, receiving stable daily doses of one to th…
  8. 08HumanRandomized controlled trialSafety outcome

    In adults with type 2 diabetes, 80% of participants had adverse events with oral semaglutide 50 mg.

    In plain wordsIn adults with type 2 diabetes, about four in five people on oral semaglutide 50 mg had a side effect.

    Peptide
    Semaglutide
    Outcome
    Not applicableAdverse events (any)
    Study

    n = 535

    Outcome group
    Adverse events · Whole body
    Studied dose
    50 mg once daily · oral · 68 weeksAs given in this study (human).

    Measurements

    Participants with adverse events
    80%
    oral semaglutide 50 mg

    Source sentences

    Summary
    428 (80%) in the 50 mg group
    1 context sentence
    Summary · context
    This global, multicentre, randomised, double-blind, phase 3b trial, carried out at 177 sites in 14 countries, enrolled adults with type 2 diabetes, glycated haemoglobin (HbA1c) 8·0-10·5% (64-91 mmol/mol), a BMI of 25·0 kg/m2 or greater, receiving stable daily doses of one to th…

AI wrote and checked these results. AI can make mistakes, so check important results against the source.

Registered trials1

Trials this study reports on, or that list this study as a reference. Registry data from ClinicalTrials.gov.

1 trial · 1 completed · 1 with posted results · source ClinicalTrials.gov (opens in a new tab)

CompletedPhase 3Results postedNCT04707469

Research Study to Compare Three Doses of Semaglutide Tablets Taken Once Daily in People With Type 2 Diabetes

Novo Nordisk A/Sn = 1,60615 Jan 2021 to 8 Mar 2023

Diabetes Mellitus, Type 2

Trial pageClinicalTrials.govUpdated 9 Dec 2025

Version history

PepBank keeps every version of the data on this study. Status changes from Retraction Watch, Europe PMC and Crossref are listed with their source.

  1. Version 2Current

    11 Oct 2026, 00:50 UTC

    Study results updated

  2. Version 1

    9 Oct 2026, 03:06 UTC

    First added · source update from Europe PMC

Subjects

Terms as the source lists them.

PepBank is a research reference. Talk to a doctor before you use any peptide.