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Study · Randomized controlled trial · n = 4,156 · 2022

4 results

Subcutaneous infusion of exenatide and cardiovascular outcomes in type 2 diabetes: a non-inferiority randomized controlled trial.

Ruff CT, Baron M, Im K, O'Donoghue ML, Fiedorek FT, Sabatine MS

Nature medicine6 Dec 2021Cited by 85 (Europe PMC)

PMID34873344 (opens in a new tab)DOI10.1038/s41591-021-01584-3 (opens in a new tab)PepBankPUB-34873344
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 trialSafety outcome

    In patients with diabetes and cardiovascular risk, ITCA 650 met the non-inferiority criterion versus placebo for the composite cardiovascular outcome.

    In plain wordsIn patients with diabetes and cardiovascular risk, ITCA 650 met the non-inferiority criterion versus placebo for the combined cardiovascular outcome.

    Peptide
    Exenatide (exendin-4)
    Outcome
    No significant changeComposite cardiovascular outcome
    Study

    n = 4,156

    Comparator
    Placebo
    Analysis
    Primary
    Outcome group
    Cardiovascular events · Cardiovascular
    Studied dose
    Dose not stated · Continuous subcutaneous infusion · Median follow-up 16 monthsAs given in this study (human).

    Measurements

    Composite cardiovascular outcome
    4.6%
    ITCA 650
    Composite cardiovascular outcome
    3.8%
    placebo
    Hazard ratio
    1.21 ratio
    ITCA 650 versus placebo

    Source sentences

    Summary
    The primary outcome occurred in 4.6% (95/2,075) of patients in the ITCA 650 group and 3.8% (79/2,081) of patients in the placebo group, meeting the pre-specified non-inferiority criterion (HR = 1.21, 95% CI, 0.90-1.63, Pnon-inferiority = 0.004).
    2 context sentences
    Summary · context
    Here, we randomly assigned patients with type 2 diabetes with, or at risk for, atherosclerotic cardiovascular disease (ASCVD) to receive ITCA 650 or placebo to assess cardiovascular safety in a pre-approval trial ( NCT01455896 ).
    Summary · context
    The primary outcome was a composite of cardiovascular death, non-fatal myocardial infarction, non-fatal stroke or hospitalization for unstable angina.
  2. 02HumanRandomized controlled trialSafety outcome

    In patients with diabetes and cardiovascular risk, adverse events were more frequent with ITCA 650 than placebo.

    In plain wordsIn patients with diabetes and cardiovascular risk, adverse events were more frequent with ITCA 650 than placebo.

    Peptide
    Exenatide (exendin-4)
    Outcome
    IncreaseAdverse events
    Study

    n = 4,144

    Comparator
    Placebo
    Outcome group
    Adverse events · Whole body
    Studied dose
    Dose not stated · Continuous subcutaneous infusion · Median follow-up 16 monthsAs given in this study (human).

    Measurements

    Adverse events
    72%
    ITCA 650
    Adverse events
    63.9%
    placebo

    Source sentences

    Summary
    Adverse events were more frequent in the ITCA 650 group (72%, 1,491/2,074) than in the placebo group (63.9%, 1,325/2,070), mainly due to an increase in gastrointestinal events and disorders while on ITCA 650.
    2 context sentences
    Summary · context
    Here, we randomly assigned patients with type 2 diabetes with, or at risk for, atherosclerotic cardiovascular disease (ASCVD) to receive ITCA 650 or placebo to assess cardiovascular safety in a pre-approval trial ( NCT01455896 ).
    Summary · context
    The primary outcome was a composite of cardiovascular death, non-fatal myocardial infarction, non-fatal stroke or hospitalization for unstable angina.
  3. 03HumanRandomized controlled trialSafety outcome

    In patients with diabetes and cardiovascular risk, serious adverse events were similar with ITCA 650 and placebo.

    In plain wordsIn patients with diabetes and cardiovascular risk, serious adverse events were similar with ITCA 650 and placebo.

    Peptide
    Exenatide (exendin-4)
    Outcome
    No significant changeSerious adverse events
    Study

    n: not reported in source

    Comparator
    Placebo
    Outcome group
    Adverse events · Whole body
    Studied dose
    Dose not stated · Continuous subcutaneous infusion · Median follow-up 16 monthsAs given in this study (human).

    Source sentences

    Summary
    Serious adverse events were similar between the two groups.
    2 context sentences
    Summary · context
    Here, we randomly assigned patients with type 2 diabetes with, or at risk for, atherosclerotic cardiovascular disease (ASCVD) to receive ITCA 650 or placebo to assess cardiovascular safety in a pre-approval trial ( NCT01455896 ).
    Summary · context
    The primary outcome was a composite of cardiovascular death, non-fatal myocardial infarction, non-fatal stroke or hospitalization for unstable angina.
  4. 04HumanRandomized controlled trialSafety outcome

    In patients with diabetes and cardiovascular risk, ITCA 650 increased gastrointestinal events and disorders versus placebo.

    In plain wordsIn patients with diabetes and cardiovascular risk, ITCA 650 increased gastrointestinal events and disorders versus placebo.

    Peptide
    Exenatide (exendin-4)
    Outcome
    IncreaseGastrointestinal events and disorders
    Study

    n: not reported in source

    Comparator
    Placebo
    Outcome group
    Gastrointestinal adverse events · Gastrointestinal
    Studied dose
    Dose not stated · Continuous subcutaneous infusion · Median follow-up 16 monthsAs given in this study (human).

    Source sentences

    Summary
    Adverse events were more frequent in the ITCA 650 group (72%, 1,491/2,074) than in the placebo group (63.9%, 1,325/2,070), mainly due to an increase in gastrointestinal events and disorders while on ITCA 650.
    2 context sentences
    Summary · context
    Here, we randomly assigned patients with type 2 diabetes with, or at risk for, atherosclerotic cardiovascular disease (ASCVD) to receive ITCA 650 or placebo to assess cardiovascular safety in a pre-approval trial ( NCT01455896 ).
    Summary · context
    The primary outcome was a composite of cardiovascular death, non-fatal myocardial infarction, non-fatal stroke or hospitalization for unstable angina.

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 · source ClinicalTrials.gov (opens in a new tab)

CompletedPhase 3NCT01455896

A Study to Evaluate Cardiovascular Outcomes in Patients With Type 2 Diabetes Treated With ITCA 650

Intarcia Therapeuticsn = 4,156Mar 2013 to Mar 2016

Type 2 Diabetes

Trial pageClinicalTrials.govUpdated 27 Jan 2017

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

    22 Oct 2026, 02:26 UTC

    Study results updated

  2. Version 1

    21 Oct 2026, 18:59 UTC

    First added · source update from Europe PMC

Subjects

Terms as the source lists them.

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