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Study · Randomized controlled trial · n = 4,076 · 2021

3 results

Cardiovascular and Renal Outcomes with Efpeglenatide in Type 2 Diabetes.

Gerstein HC, Sattar N, Rosenstock J, Ramasundarahettige C, Pratley R, Lopes RD, Lam CSP, Khurmi NS, Heenan L, Del Prato S, Dyal L, Branch K

The New England journal of medicine28 Jun 2021Cited by 699 (Europe PMC)

PMID34215025 (opens in a new tab)DOI10.1056/nejmoa2108269 (opens in a new tab)PepBankPUB-34215025
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 study3

3 results from studies that gave the peptide. 3 results from people.

  1. 01HumanRandomized controlled trialEfficacy outcome

    In high-risk participants with diabetes, efpeglenatide reduced MACE versus placebo (7.0% versus 9.2%; HR 0.73, 95% CI 0.58-0.92; superiority P=0.007).

    In plain wordsIn high-risk participants with diabetes, efpeglenatide reduced major cardiovascular events compared with placebo.

    Peptide
    Efpeglenatide
    Outcome
    DecreaseMajor adverse cardiovascular event
    Study

    n = 4,076

    Comparator
    Placebo
    Analysis
    Primary
    Outcome group
    Cardiovascular events · Cardiovascular
    Studied dose
    4 or 6 mg weekly · subcutaneous · median follow-up 1.81 yearsAs given in this study (human).

    Measurements

    Participants with MACE
    189 participants
    efpeglenatide
    Participants with MACE
    7%
    efpeglenatide
    MACE rate
    3.9 events per 100 person-years
    efpeglenatide
    Participants with MACE
    125 participants
    placebo
    Participants with MACE
    9.2%
    placebo
    MACE rate
    5.3 events per 100 person-years
    placebo
    Hazard ratio
    0.73 HR
    efpeglenatide versus placebo
    Hazard ratio 95% CI
    0.58 to 0.92 HR
    efpeglenatide versus placebo

    Source sentences

    Summary
    During a median follow-up of 1.81 years, an incident MACE occurred in 189 participants (7.0%) assigned to receive efpeglenatide (3.9 events per 100 person-years) and 125 participants (9.2%) assigned to receive placebo (5.3 events per 100 person-years) (hazard ratio, 0.73; 95% confidence interval [CI…
    1 context sentence
    Summary · context
    Participants were randomly assigned in a 1:1:1 ratio to receive weekly subcutaneous injections of efpeglenatide at a dose of 4 or 6 mg or placebo.
  2. 02HumanRandomized controlled trialEfficacy outcome

    In high-risk participants with diabetes, efpeglenatide reduced renal composite events versus placebo (13.0% versus 18.4%; HR 0.68, 95% CI 0.57-0.79; P<0.001).

    In plain wordsIn high-risk participants with diabetes, efpeglenatide reduced kidney composite events compared with placebo.

    Peptide
    Efpeglenatide
    Outcome
    DecreaseComposite renal outcome
    Study

    n = 4,076

    Comparator
    Placebo
    Outcome group
    Kidney function · Kidney and urinary
    Studied dose
    4 or 6 mg weekly · subcutaneous · median follow-up 1.81 yearsAs given in this study (human).

    Measurements

    Participants with composite renal outcome
    353 participants
    efpeglenatide
    Participants with composite renal outcome
    13%
    efpeglenatide
    Participants with composite renal outcome
    250 participants
    placebo
    Participants with composite renal outcome
    18.4%
    placebo
    Hazard ratio
    0.68 HR
    efpeglenatide versus placebo
    Hazard ratio 95% CI
    0.57 to 0.79 HR
    efpeglenatide versus placebo

    Source sentences

    Summary
    A composite renal outcome event (a decrease in kidney function or macroalbuminuria) occurred in 353 participants (13.0%) assigned to receive efpeglenatide and in 250 participants (18.4%) assigned to receive placebo (hazard ratio, 0.68; 95% CI, 0.57 to 0.79; P<0.001).
    1 context sentence
    Summary · context
    Participants were randomly assigned in a 1:1:1 ratio to receive weekly subcutaneous injections of efpeglenatide at a dose of 4 or 6 mg or placebo.
  3. 03HumanRandomized controlled trialSafety outcome

    In high-risk participants with diabetes, diarrhea, constipation, nausea, vomiting, or bloating occurred more frequently with efpeglenatide than placebo.

    In plain wordsIn high-risk participants with diabetes, diarrhea, constipation, nausea, vomiting, or bloating occurred more often with efpeglenatide than with placebo.

    Peptide
    Efpeglenatide
    Outcome
    IncreaseDiarrhea, constipation, nausea, vomiting, or bloating
    Study

    n = 4,076

    Comparator
    Placebo
    Outcome group
    Gastrointestinal adverse events · Gastrointestinal
    Studied dose
    4 or 6 mg weekly · subcutaneous · median follow-up 1.81 yearsAs given in this study (human).

    Source sentences

    Summary
    Diarrhea, constipation, nausea, vomiting, or bloating occurred more frequently with efpeglenatide than with placebo.
    1 context sentence
    Summary · context
    Participants were randomly assigned in a 1:1:1 ratio to receive weekly subcutaneous injections of efpeglenatide at a dose of 4 or 6 mg or placebo.

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

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

    27 Oct 2026, 18:20 UTC

    Study results updated

  2. Version 1

    27 Oct 2026, 16:32 UTC

    First added · source update from Europe PMC

Subjects

Terms as the source lists them.

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