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Study · Randomized controlled trial · n = 13,165 · 2025

6 results

Cardiovascular Outcomes with Tirzepatide versus Dulaglutide in Type 2 Diabetes.

Nicholls SJ, Pavo I, Bhatt DL, Buse JB, Del Prato S, Kahn SE, Lincoff AM, McGuire DK, Miller D, Nauck MA, Nishiyama H, Nissen SE and 15 more

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Sattar N, Weerakkody G, Wiese RJ, Zinman B, Zoungas S, Basile J, Davies MJ, Giorgino F, Kellerer M, Ji L, Varkonyi T, Menon V, Broder JC, Herschtal A, D'Alessio D

The New England journal of medicine1 Dec 2025Cited by 84 (Europe PMC)

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 study6

6 results from studies that gave the peptide. 6 results from people.

  1. 01HumanRandomized controlled trialEfficacy outcome

    In adults with type 2 diabetes and atherosclerotic cardiovascular disease, tirzepatide was noninferior to dulaglutide for the primary composite end point, and superiority was not shown.

    In plain wordsIn adults with type 2 diabetes and heart disease, tirzepatide was as good as dulaglutide for heart events. It was not shown to be better.

    Outcome
    No significant changeComposite of cardiovascular death, myocardial infarction or stroke
    Study

    n = 13,165

    Comparator
    Dulaglutide 1.5 mg
    Analysis
    Primary
    Outcome group
    Cardiovascular events · Cardiovascular
    Studied dose
    up to 15 mg once weekly · subcutaneousAs given in this study (human).

    Measurements

    Hazard ratio
    0.92 ratio
    tirzepatide vs dulaglutide
    Event proportion
    12.2%
    tirzepatide
    Event proportion
    13.1%
    dulaglutide

    Source sentences

    Summary
    A primary end-point event occurred in 801 patients (12.2%) in the tirzepatide group and 862 (13.1%) in the dulaglutide group (hazard ratio, 0.92; 95.3% confidence interval, 0.83 to 1.01; P = 0.003 for noninferiority; P = 0.09 for superiority).
    1 context sentence
    Summary · context
    We conducted an active-comparator-controlled, double-blind, noninferiority trial in which patients with type 2 diabetes and atherosclerotic cardiovascular disease were randomly assigned in a 1:1 ratio to receive a weekly subcutaneous injection of tirzepatide (up to 15 mg) or dulaglutide (1.5 mg), an…
  2. 02HumanRandomized controlled trialEfficacy outcome

    In patients with T2D and atherosclerotic cardiovascular disease, tirzepatide was noninferior but not superior to dulaglutide for the primary cardiovascular composite.

    In plain wordsIn patients with diabetes and cardiovascular disease, tirzepatide was noninferior to dulaglutide for major cardiovascular events, without significant superiority.

    Outcome
    No significant changeCardiovascular death, myocardial infarction, or stroke composite
    Study

    n = 13,165

    Comparator
    Tirzepatide up to 15 mg
    Analysis
    Primary
    Outcome group
    Cardiovascular events · Cardiovascular
    Studied dose
    1.5 mg weekly · subcutaneousAs given in this study (human).

    Measurements

    Primary endpoint events
    862 patients
    dulaglutide
    Primary endpoint incidence
    13.1%
    dulaglutide
    Primary endpoint events
    801 patients
    tirzepatide
    Primary endpoint incidence
    12.2%
    tirzepatide
    Hazard ratio
    0.92 ratio
    tirzepatide versus dulaglutide
    95.3% confidence interval of hazard ratio
    0.83 to 1.01 ratio
    tirzepatide versus dulaglutide

    Source sentences

    Summary
    A primary end-point event occurred in 801 patients (12.2%) in the tirzepatide group and 862 (13.1%) in the dulaglutide group (hazard ratio, 0.92; 95.3% confidence interval, 0.83 to 1.01; P = 0.003 for noninferiority; P = 0.09 for superiority).
    2 context sentences
    Summary · context
    The primary end point was a composite of death from cardiovascular causes, myocardial infarction, or stroke and was tested for noninferiority of tirzepatide to dulaglutide with a margin of 1.05 for the upper limit of the 95.3% confidence interval for the hazard ratio.
    Summary · context
    patients with type 2 diabetes and atherosclerotic cardiovascular disease were randomly assigned in a 1:1 ratio to receive a weekly subcutaneous injection of tirzepatide (up to 15 mg) or dulaglutide (1.5 mg)
  3. 03HumanRandomized controlled trialSafety outcome

    In adults with type 2 diabetes and atherosclerotic cardiovascular disease, the overall incidence of adverse events appeared similar with tirzepatide and dulaglutide.

    In plain wordsIn adults with type 2 diabetes and heart disease, side effects overall seemed similar with tirzepatide and dulaglutide.

    Outcome
    No significant changeOverall incidence of adverse events
    Study

    n: not reported in source

    Comparator
    Dulaglutide 1.5 mg
    Outcome group
    Adverse events · Whole body
    Studied dose
    up to 15 mg once weekly · subcutaneousAs given in this study (human).

    Source sentences

    Summary
    The incidence of adverse events appeared to be similar in the two groups, although more gastrointestinal adverse events were observed in the tirzepatide group.
    1 context sentence
    Summary · context
    We conducted an active-comparator-controlled, double-blind, noninferiority trial in which patients with type 2 diabetes and atherosclerotic cardiovascular disease were randomly assigned in a 1:1 ratio to receive a weekly subcutaneous injection of tirzepatide (up to 15 mg) or dulaglutide (1.5 mg), an…
  4. 04HumanRandomized controlled trialSafety outcome

    In adults with type 2 diabetes and atherosclerotic cardiovascular disease, more gastrointestinal adverse events were observed with tirzepatide than with dulaglutide.

    In plain wordsIn adults with type 2 diabetes and heart disease, tirzepatide caused more stomach and gut side effects than dulaglutide.

    Outcome
    IncreaseGastrointestinal adverse events
    Study

    n: not reported in source

    Comparator
    Dulaglutide 1.5 mg
    Outcome group
    Gastrointestinal adverse events · Gastrointestinal
    Studied dose
    up to 15 mg once weekly · subcutaneousAs given in this study (human).

    Source sentences

    Summary
    The incidence of adverse events appeared to be similar in the two groups, although more gastrointestinal adverse events were observed in the tirzepatide group.
    1 context sentence
    Summary · context
    We conducted an active-comparator-controlled, double-blind, noninferiority trial in which patients with type 2 diabetes and atherosclerotic cardiovascular disease were randomly assigned in a 1:1 ratio to receive a weekly subcutaneous injection of tirzepatide (up to 15 mg) or dulaglutide (1.5 mg), an…
  5. 05HumanRandomized controlled trialSafety outcome

    In patients with T2D and atherosclerotic cardiovascular disease, adverse event incidence appeared similar with dulaglutide and tirzepatide.

    In plain wordsIn patients with diabetes and cardiovascular disease, overall adverse event rates appeared similar with dulaglutide and tirzepatide.

    Outcome
    No significant changeAdverse events
    Study

    n: not reported in source

    Comparator
    Tirzepatide up to 15 mg
    Outcome group
    Adverse events · Whole body
    Studied dose
    1.5 mg weekly · subcutaneousAs given in this study (human).

    Source sentences

    Summary
    The incidence of adverse events appeared to be similar in the two groups, although more gastrointestinal adverse events were observed in the tirzepatide group.
    1 context sentence
    Summary · context
    patients with type 2 diabetes and atherosclerotic cardiovascular disease were randomly assigned in a 1:1 ratio to receive a weekly subcutaneous injection of tirzepatide (up to 15 mg) or dulaglutide (1.5 mg)
  6. 06HumanRandomized controlled trialSafety outcome

    In patients with T2D and atherosclerotic cardiovascular disease, gastrointestinal adverse events were less frequent with dulaglutide than tirzepatide.

    In plain wordsIn patients with diabetes and cardiovascular disease, dulaglutide caused fewer digestive adverse events than tirzepatide.

    Outcome
    DecreaseGastrointestinal adverse events
    Study

    n: not reported in source

    Comparator
    Tirzepatide up to 15 mg
    Outcome group
    Gastrointestinal adverse events · Gastrointestinal
    Studied dose
    1.5 mg weekly · subcutaneousAs given in this study (human).

    Source sentences

    Summary
    The incidence of adverse events appeared to be similar in the two groups, although more gastrointestinal adverse events were observed in the tirzepatide group.
    1 context sentence
    Summary · context
    patients with type 2 diabetes and atherosclerotic cardiovascular disease were randomly assigned in a 1:1 ratio to receive a weekly subcutaneous injection of tirzepatide (up to 15 mg) or dulaglutide (1.5 mg)

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

Registered trials2

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

2 trials · 1 not yet recruiting · 1 completed · 1 with posted results · source ClinicalTrials.gov (opens in a new tab)

Not yet recruitingPhase not statedNCT07567378

CARTIZ Registry: Cartilage, Arthropathy and Imaging Under Tirzepatide in Zone-stratified Cohorts - A Four-Institute Mexican Observational Registry

JULIO GRANADOS MONTIELn = 30est. May 2026 to est. May 2029

Psoriatic Arthritis · Osteoarthitis · Knee · Diabetes (DM) · Type 2 Diabetes Mellitus (T2DM) · Obesity (Disorder) · Insulin Resistance Syndrome · Metabolic Syndrome · Heart Failure · Preserved Ejection Fraction · Coronary Artery Disease · Atrial Fibrillation (AF) · Non Alcholic Fatty Liver Disease · Sarcopenia · Pericardium

Trial pageClinicalTrials.govUpdated 12 May 2026
CompletedPhase 3Results postedNCT04255433

A Study of Tirzepatide (LY3298176) Compared With Dulaglutide on Major Cardiovascular Events in Participants With Type 2 Diabetes

Eli Lilly and Companyn = 13,29929 May 2020 to 12 Jun 2025

Type 2 Diabetes Mellitus

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. Versions 4 to 8Current

    28 Oct 2026, 02:03 UTC

    The same notice was added 5 times, first on 22 Oct 2026, 02:26 UTC. The status did not change between them.

    Study results updated

  2. Version 3

    21 Oct 2026, 18:59 UTC

    Study data updated · source update from Europe PMC

  3. Version 2

    12 Oct 2026, 12:58 UTC

    Study results updated

  4. Version 1

    9 Oct 2026, 03:07 UTC

    First added · source update from Europe PMC

Subjects

Terms as the source lists them.

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