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Study · Randomized controlled trial · n = 9,901 · 2019

3 results

Dulaglutide and cardiovascular outcomes in type 2 diabetes (REWIND): a double-blind, randomised placebo-controlled trial.

Gerstein HC, Colhoun HM, Dagenais GR, Diaz R, Lakshmanan M, Pais P, Probstfield J, Riesmeyer JS, Riddle MC, Rydén L, Xavier D, Atisso CM and 25 more

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Dyal L, Hall S, Rao-Melacini P, Wong G, Avezum A, Basile J, Chung N, Conget I, Cushman WC, Franek E, Hancu N, Hanefeld M, Holt S, Jansky P, Keltai M, Lanas F, Leiter LA, Lopez-Jaramillo P, Cardona Munoz EG, Pirags V, Pogosova N, Raubenheimer PJ, Shaw JE, Sheu WH, Temelkova-Kurktschiev T

Lancet (London, England)9 Jun 2019Cited by 2,264 (Europe PMC)

PMID31189511 (opens in a new tab)DOI10.1016/s0140-6736(19)31149-3 (opens in a new tab)PepBankPUB-31189511
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 T2D patients with cardiovascular disease or risk factors, dulaglutide reduced the primary composite cardiovascular outcome versus placebo.

    In plain wordsIn T2D patients with cardiovascular disease or risk factors, dulaglutide reduced the combined cardiovascular outcome compared with placebo.

    Peptide
    Dulaglutide (Trulicity)
    Outcome
    DecreaseMajor adverse cardiovascular events
    Study

    n = 9,901

    Comparator
    Placebo
    Analysis
    Primary
    Outcome group
    Cardiovascular events · Cardiovascular
    Studied dose
    1.5 mg weekly · subcutaneous · Median follow-up 5.4 yearsAs given in this study (human).

    Measurements

    Primary outcome
    12%
    dulaglutide
    Primary outcome
    13.4%
    placebo
    Hazard ratio
    0.88 ratio
    dulaglutide versus placebo
    Primary outcome
    594 participants
    dulaglutide
    Primary outcome
    663 participants
    placebo
    Incidence rate
    2.4 per 100 person-years
    dulaglutide
    Incidence rate
    2.7 per 100 person-years
    placebo

    Source sentences

    Summary
    During a median follow-up of 5·4 years (IQR 5·1-5·9), the primary composite outcome occurred in 594 (12·0%) participants at an incidence rate of 2·4 per 100 person-years in the dulaglutide group and in 663 (13·4%) participants at an incidence rate of 2·7 per 100 person-years in the placebo group (ha…
    2 context sentences
    Summary · context
    The primary outcome was the first occurrence of the composite endpoint of non-fatal myocardial infarction, non-fatal stroke, or death from cardiovascular causes (including unknown causes), which was assessed in the intention-to-treat population.
    Summary · context
    Men and women aged at least 50 years with type 2 diabetes who had either a previous cardiovascular event or cardiovascular risk factors were randomly assigned (1:1) to either weekly subcutaneous injection of dulaglutide (1·5 mg) or placebo.
  2. 02HumanRandomized controlled trialSafety outcome

    In T2D patients with cardiovascular disease or risk factors, all-cause mortality did not differ significantly between dulaglutide and placebo.

    In plain wordsIn T2D patients with cardiovascular disease or risk factors, deaths did not differ significantly between dulaglutide and placebo.

    Peptide
    Dulaglutide (Trulicity)
    Outcome
    No significant changeAll-cause mortality
    Study

    n = 9,901

    Comparator
    Placebo
    Outcome group
    Mortality · Whole body
    Studied dose
    1.5 mg weekly · subcutaneous · Median follow-up 5.4 yearsAs given in this study (human).

    Measurements

    Deaths
    536 participants
    dulaglutide
    Mortality
    10.8%
    dulaglutide
    Hazard ratio
    0.9 ratio
    dulaglutide versus placebo
    Deaths
    592 participants
    placebo
    Mortality
    12%
    placebo

    Source sentences

    Summary
    All-cause mortality did not differ between groups (536 [10·8%] in the dulaglutide group vs 592 [12·0%] in the placebo group; HR 0·90, 95% CI 0·80-1·01; p=0·067).
    1 context sentence
    Summary · context
    Men and women aged at least 50 years with type 2 diabetes who had either a previous cardiovascular event or cardiovascular risk factors were randomly assigned (1:1) to either weekly subcutaneous injection of dulaglutide (1·5 mg) or placebo.
  3. 03HumanRandomized controlled trialSafety outcome

    In T2D patients with cardiovascular disease or risk factors, gastrointestinal adverse events were more frequent with dulaglutide than placebo.

    In plain wordsIn T2D patients with cardiovascular disease or risk factors, stomach and bowel events were more frequent with dulaglutide than placebo.

    Peptide
    Dulaglutide (Trulicity)
    Outcome
    IncreaseGastrointestinal adverse events
    Study

    n = 9,901

    Comparator
    Placebo
    Outcome group
    Gastrointestinal adverse events · Gastrointestinal
    Studied dose
    1.5 mg weekly · subcutaneous · Median follow-up 5.4 yearsAs given in this study (human).

    Measurements

    Gastrointestinal adverse events
    47.4%
    dulaglutide
    Gastrointestinal adverse events
    34.1%
    placebo
    Gastrointestinal adverse events
    2347 participants
    dulaglutide
    Gastrointestinal adverse events
    1687 participants
    placebo

    Source sentences

    Summary
    2347 (47·4%) participants assigned to dulaglutide reported a gastrointestinal adverse event during follow-up compared with 1687 (34·1%) participants assigned to placebo (p<0·0001).
    1 context sentence
    Summary · context
    Men and women aged at least 50 years with type 2 diabetes who had either a previous cardiovascular event or cardiovascular risk factors were randomly assigned (1:1) to either weekly subcutaneous injection of dulaglutide (1·5 mg) or placebo.

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

Registered trials6

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

6 trials · 4 ongoing · 2 completed · 1 with posted results · source ClinicalTrials.gov (opens in a new tab)

RecruitingPhase 2/3NCT07284511

A Clinical Trial Using Tirzepatide to Help Adults With Type 1 Diabetes Automatically Control Their Blood Sugar

McGill University Health Centre/Research Institute of the McGill University Health Centren = 10519 May 2026 to est. Jan 2029

Type 1 Diabetes · Type 1 Diabetes Mellitus · T1D · T1DM · T1DM - Type 1 Diabetes Mellitus

Trial pageClinicalTrials.govUpdated 27 May 2026
RecruitingPhase 3NCT06894784

A Clinical Trial to Evaluate The Effects of Semaglutide and Empagliflozin Combined to Automated Insulin Delivery on Diabetes Control in Adults Living With Type 1 Diabetes

McGill University Health Centre/Research Institute of the McGill University Health Centren = 36est. Apr 2025 to est. Jan 2027

Diabetes Type 1

Trial pageClinicalTrials.govUpdated 30 Mar 2025
RecruitingPhase 4NCT06606821

The Effects of Tirzepatide in People With Overweight/Obesity and Coronary Artery Disease

Tina Vilsbølln = 1241 Oct 2024 to est. 1 Aug 2028

Coronary Artery Disease · Coronary Microvascular Dysfunction · Overweight or Obesity · Stable Angina Pectoris · Chronic Coronary Artery Disease · Atherosclerosis Cardiovascular Disease

Trial pageClinicalTrials.govUpdated 22 May 2025
RecruitingPhase 2NCT05478707

Therapeutic Strategies for Microvascular Dysfunction in Type 1 Diabetes

AdventHealth Translational Research Instituten = 475 Oct 2023 to est. 30 Jul 2028

Diabetes Mellitus, Type 1 · Endothelial Dysfunction

Trial pageClinicalTrials.govUpdated 15 Oct 2026
CompletedPhase not statedNCT05136287

SEMAGLUTIDE VERSUS GLP-1 RECEPTOR AGONISTS. EFFECTIVENESS , SAFETY AND QUALITY OF LIFE IN PATIENTS WITH DIABETES MELLITUS 2. OBSERVATIONAL, PROSPECTIVE AND MULTICENTER STUDY. SEVERAL STUDY.

Jose Seijas Amigon = 1401 Feb 2022 to 1 Jan 2024

Weight Loss · Diabetes Mellitus, Type 2 · Quality of Life · Safety Issues

Trial pageClinicalTrials.govUpdated 28 Feb 2024
CompletedPhase 3Results postedNCT01394952

Researching Cardiovascular Events With a Weekly Incretin in Diabetes (REWIND)

Eli Lilly and Companyn = 9,90122 Jul 2011 to 21 Aug 2018

Cardiovascular Disease · Diabetes Mellitus, Type 2

Trial pageClinicalTrials.govUpdated 8 Oct 2019

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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