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Study · Randomized controlled trial · n = 9,650 · 2025

4 results

Oral Semaglutide and Cardiovascular Outcomes in High-Risk Type 2 Diabetes.

McGuire DK, Marx N, Mulvagh SL, Deanfield JE, Inzucchi SE, Pop-Busui R, Mann JFE, Emerson SS, Poulter NR, Engelmann MDM, Ripa MS, Hovingh GK and 6 more

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Brown-Frandsen K, Bain SC, Cavender MA, Gislum M, David JP, Buse JB

The New England journal of medicine29 Mar 2025Cited by 252 (Europe PMC)

PMID40162642 (opens in a new tab)DOI10.1056/nejmoa2501006 (opens in a new tab)PepBankPUB-40162642
Publisher pagePubMedAsk about this study
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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 study4

4 results from studies that gave the peptide. 4 results from people.

  1. 01HumanRandomized controlled trialEfficacy outcome

    In adults with type 2 diabetes and atherosclerotic cardiovascular disease, chronic kidney disease, or both, oral semaglutide lowered major cardiovascular events versus placebo (hazard ratio 0.86; 12.0% vs 13.8%).

    In plain wordsIn adults with type 2 diabetes and heart or kidney disease, oral semaglutide lowered the risk of major cardiovascular events compared with placebo.

    Peptide
    Semaglutide
    Outcome
    DecreaseMajor adverse cardiovascular events (time to first event)
    Study

    n = 9,650

    Comparator
    Placebo
    Analysis
    Primary
    Outcome group
    Cardiovascular events · Cardiovascular
    Studied dose
    maximal dose 14 mg once daily · oralAs given in this study (human).

    Measurements

    Hazard ratio
    0.86 ratio
    oral semaglutide vs placebo
    Event rate
    12%
    oral semaglutide
    Event rate
    13.8%
    placebo

    Source sentences

    Summary
    A primary-outcome event occurred in 579 of the 4825 participants (12.0%; incidence, 3.1 events per 100 person-years) in the oral semaglutide group, as compared with 668 of the 4825 participants (13.8%; incidence, 3.7 events per 100 person-years) in the placebo group (hazard ratio, 0.86; 95% confiden…
    3 context sentences
    Summary · context
    The primary outcome was major adverse cardiovascular events (a composite of death from cardiovascular causes, nonfatal myocardial infarction, or nonfatal stroke), assessed in a time-to-first-event analysis.
    Summary · context
    Among the 9650 participants who had undergone randomization, the mean (±SD) follow-up was 47.5±10.9 months, and the median follow-up was 49.5 months.
    Summary · context
    we randomly assigned participants who were 50 years of age or older, had type 2 diabetes with a glycated hemoglobin level of 6.5 to 10.0%, and had known atherosclerotic cardiovascular disease, chronic kidney disease, or both to receive either once-daily oral semaglutide (maximal dose, 14 mg) or placebo
  2. 02HumanRandomized controlled trialEfficacy outcome

    The confirmatory secondary outcomes, including major kidney disease events, did not differ significantly between oral semaglutide and placebo.

    In plain wordsOral semaglutide and placebo did not differ significantly on the confirmatory secondary outcomes, which included major kidney disease events.

    Peptide
    Semaglutide
    Outcome
    No significant changeConfirmatory secondary outcomes, including major kidney disease events
    Study

    n = 9,650

    Comparator
    Placebo
    Analysis
    Secondary
    Outcome group
    Kidney function · Kidney and urinary
    Studied dose
    maximal dose 14 mg once daily · oralAs given in this study (human).

    Source sentences

    Summary
    The results for the confirmatory secondary outcomes did not differ significantly between the two groups.
    2 context sentences
    Summary · context
    The confirmatory secondary outcomes included major kidney disease events (a five-point composite outcome).
    Summary · context
    we randomly assigned participants who were 50 years of age or older, had type 2 diabetes with a glycated hemoglobin level of 6.5 to 10.0%, and had known atherosclerotic cardiovascular disease, chronic kidney disease, or both to receive either once-daily oral semaglutide (maximal dose, 14 mg) or placebo
  3. 03HumanRandomized controlled trialSafety outcome

    Serious adverse events occurred in 47.9% with oral semaglutide and 50.3% with placebo, with no increase under semaglutide.

    In plain wordsSerious side effects were no more common with oral semaglutide (47.9%) than with placebo (50.3%).

    Peptide
    Semaglutide
    Outcome
    No significant changeSerious adverse events
    Study

    n = 9,650

    Comparator
    Placebo
    Outcome group
    Adverse events · Whole body
    Studied dose
    maximal dose 14 mg once daily · oralAs given in this study (human).

    Measurements

    Serious adverse events
    47.9%
    oral semaglutide
    Serious adverse events
    50.3%
    placebo

    Source sentences

    Summary
    The incidence of serious adverse events was 47.9% in the oral semaglutide group and 50.3% in the placebo group; the incidence of gastrointestinal disorders was 5.0% and 4.4%, respectively.
    2 context sentences
    Summary · context
    without an increase in the incidence of serious adverse events.
    Summary · context
    we randomly assigned participants who were 50 years of age or older, had type 2 diabetes with a glycated hemoglobin level of 6.5 to 10.0%, and had known atherosclerotic cardiovascular disease, chronic kidney disease, or both to receive either once-daily oral semaglutide (maximal dose, 14 mg) or placebo
  4. 04HumanRandomized controlled trialSafety outcome

    Gastrointestinal disorders occurred in 5.0% with oral semaglutide and 4.4% with placebo; the abstract gives no test of this difference.

    In plain wordsStomach and gut problems were reported in 5.0% on oral semaglutide and 4.4% on placebo.

    Peptide
    Semaglutide
    Outcome
    Direction not reportedGastrointestinal disorders
    Study

    n = 9,650

    Comparator
    Placebo
    Outcome group
    Gastrointestinal adverse events · Gastrointestinal
    Studied dose
    maximal dose 14 mg once daily · oralAs given in this study (human).

    Measurements

    Gastrointestinal disorders
    5%
    oral semaglutide
    Gastrointestinal disorders
    4.4%
    placebo

    Source sentences

    Summary
    the incidence of gastrointestinal disorders was 5.0% and 4.4%, respectively.
    1 context sentence
    Summary · context
    we randomly assigned participants who were 50 years of age or older, had type 2 diabetes with a glycated hemoglobin level of 6.5 to 10.0%, and had known atherosclerotic cardiovascular disease, chronic kidney disease, or both to receive either once-daily oral semaglutide (maximal dose, 14 mg) or placebo

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 postedNCT03914326

A Heart Disease Study of Semaglutide in Patients With Type 2 Diabetes

Novo Nordisk A/Sn = 9,65117 Jun 2019 to 23 Aug 2024

Diabetes Mellitus, Type 2

Trial pageClinicalTrials.govUpdated 11 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, 00:04 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.

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