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Trial · Interventional

CompletedPhase 3Results postedRegistry data

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

Short name REWIND

NCTNCT01394952 (opens ClinicalTrials.gov in a new tab)Other id13438Other idH9X-MC-GBDJ
Open at ClinicalTrials.govAsk about this trial

Overview

Status
Completed
Phase
Phase 3
Enrollment
9,901 participants (actual)
Sponsor
Eli Lilly and Company · Industry
Design
Randomized · Double masking
Countries
25 countries

United States, Argentina, Australia, Brazil, Bulgaria, Canada, Chile, Colombia, Czechia, Germany, Hungary, Latvia, Lithuania, Mexico, New Zealand, Poland, Puerto Rico, Romania, Russia, South Africa, South Korea, Spain, Sweden, Taiwan, United Kingdom

Start
22 Jul 2011
Primary completion
21 Aug 2018
Completion
21 Aug 2018
First posted
15 Jul 2011 (estimated)
Last update posted
8 Oct 2019
Conditions
Cardiovascular Disease · Diabetes Mellitus, Type 2

Timeline

1 trial · 1 completed · 1 with posted results

  • Completed
  • Ongoing
  • Not yet recruiting
  • Stopped
  • Estimated dates (est.)
  • Results posted
2012201420162018
  1. Ph 3

    REWIND

    NCT01394952

    22 Jul 2011 to 21 Aug 2018

Registry summary

Text and fields below are the sponsor's entries at ClinicalTrials.gov, shown as posted.

The purpose of this trial is to assess whether dulaglutide can reduce major cardiovascular events and other serious outcomes in persons with type 2 diabetes, when added to their anti-hyperglycemic regimen.

Interventions

  • DulaglutideDrug
  • PlaceboDrug

Arms2

  • Experimental

    1.5 mg Dulaglutide

    Administered once weekly, subcutaneously

  • Placebo comparator

    Placebo

    Administered once weekly, subcutaneously

Primary outcomes1

Outcomes the sponsor listed as primary.

  1. Number of Participants Who Experienced an Event For Time, From Randomization to First Occurrence of Cardiovascular Death, Non-fatal Myocardial Infarction, or Non-fatal Stroke (a Composite Cardiovascular Outcome)

    Time frame · From randomization to first occurrence or death from any cause or study completion (Median Follow-Up of 5.4 Years)

    Registry description

    The time from randomization to first occurrence of cardiovascular death, non-fatal myocardial infarction, or non-fatal stroke (a composite endpoint) was evaluated using time-to-event analysis. The primary analysis model was a Cox proportional hazards regression model for the time to the first occurrence of a primary endpoint event, with treatment as a fixed effect using the intent-to-treat population. The number of participants who experienced a primary cardiovascular (CV) endpoint event is presented.

Secondary outcomes(5)

  1. Number of Participants Who Experienced an Event for Time to First Occurrence After Randomization of Cardiovascular Death, Non-fatal Myocardial Infarction, or Non-fatal Stroke, Individually

    Time frame · From randomization to first occurrence or study completion (Median Follow-Up of 5.4 Years)

    Registry description

    The time from randomization to first occurrence of cardiovascular death, non-fatal myocardial infarction, or non-fatal stroke (individually) was evaluated using time-to-event analysis via the Cox proportional hazards regression model where response equals treatment. Death from CV causes is defined as a death resulting from an acute myocardial infarction (MI), sudden cardiac death, death due to heart failure, death due to stroke, or death due to other CV causes. The number of participants who experienced an event is presented.

  2. Number of Participants Who Experienced an Event for Time to All-cause Mortality

    Time frame · From randomization to study completion (Median Follow-Up of 5.4 Years)

    Registry description

    The time to all-cause mortality was evaluated using time-to-event analysis via the Cox proportional hazards regression model where response equals treatment. The number of participants who experienced an event is presented.

  3. Number of Participants Who Experienced an Event for Time to First Occurrence After Randomization of the Composite Microvascular Endpoint

    Time frame · From randomization to first occurrence or study completion (Median Follow-Up of 5.4 Years)

    Registry description

    The time from randomization to first occurrence of the composite microvascular endpoint was evaluated using time-to-event analysis via the Cox proportional hazards regression model where response equals treatment. The composite microvascular endpoint is defined as diabetic retinopathy requiring laser therapy, vitrectomy, or anti-vascular endothelial growth factor therapy (VEGF), clinical proteinuria, a greater than equal ≥ 30% decline in estimated glomerular filtration rate, or need for chronic renal replacement therapy. The number of participants who experienced the composite microvascular endpoint event is presented.

  4. Number of Participants Who Experienced An Event for Time to First Occurrence After Randomization of Heart Failure Requiring Hospitalization or an Urgent Heart Failure Clinic Visit

    Time frame · From randomization to first occurrence or study completion (Median Follow-Up of 5.4 Years)

    Registry description

    The time to first occurrence after randomization of heart failure requiring hospitalization or an urgent heart failure clinic visit was evaluated using time-to-event analysis via the Cox proportional hazards regression model where response equals treatment. The number of participants who experienced an event is presented.

  5. Number of Participants Who Experienced an Event for Time to First Occurrence After Randomization of First Hospitalization for Unstable Angina

    Time frame · From randomization to first occurrence or study completion (Median Follow-Up of 5.4 Years)

    Registry description

    Time to first occurrence after randomization of first hospitalization for unstable angina was evaluated using time-to-event analysis via the Cox proportional hazards regression model where response equals treatment. The number of participants who experienced an event is presented.

Posted results

Values are shown as posted at ClinicalTrials.gov, with their units. PepBank has not converted, pooled or compared them.

Primary outcome results

Primary outcomeCount of participants· From randomization to first occurrence or death from any cause or study completion (Median Follow-Up of 5.4 Years)

Number of Participants Who Experienced an Event For Time, From Randomization to First Occurrence of Cardiovascular Death, Non-fatal Myocardial Infarction, or Non-fatal Stroke (a Composite Cardiovascular Outcome)

GroupValue (Participants)
Placebo663
Dulaglutide594
Secondary and other outcome results(5)
Secondary outcomeCount of participants· From randomization to first occurrence or study completion (Median Follow-Up of 5.4 Years)

Number of Participants Who Experienced an Event for Time to First Occurrence After Randomization of Cardiovascular Death, Non-fatal Myocardial Infarction, or Non-fatal Stroke, Individually

GroupValue (Participants)
Placebo346
Dulaglutide317
Secondary outcomeCount of participants· From randomization to study completion (Median Follow-Up of 5.4 Years)

Number of Participants Who Experienced an Event for Time to All-cause Mortality

GroupValue (Participants)
Placebo592
Dulaglutide536
Secondary outcomeCount of participants· From randomization to first occurrence or study completion (Median Follow-Up of 5.4 Years)

Number of Participants Who Experienced an Event for Time to First Occurrence After Randomization of the Composite Microvascular Endpoint

GroupValue (Participants)
Placebo1241
Dulaglutide1099
Secondary outcomeCount of participants· From randomization to first occurrence or study completion (Median Follow-Up of 5.4 Years)

Number of Participants Who Experienced An Event for Time to First Occurrence After Randomization of Heart Failure Requiring Hospitalization or an Urgent Heart Failure Clinic Visit

GroupValue (Participants)
Placebo226
Dulaglutide213
Secondary outcomeCount of participants· From randomization to first occurrence or study completion (Median Follow-Up of 5.4 Years)

Number of Participants Who Experienced an Event for Time to First Occurrence After Randomization of First Hospitalization for Unstable Angina

GroupValue (Participants)
Placebo77
Dulaglutide88

Adverse events, as posted

Adverse events as posted: participants affected out of participants at risk, by group
GroupDeathsSerious eventsOther events
PlaceboPlacebo was administered once weekly, subcutaneously592 / 49492044 / 49493363 / 4949
Dulaglutide1.5 mg Dulaglutide was administered once weekly, subcutaneously536 / 49431991 / 49433574 / 4943

Each cell reads participants affected / participants at risk, as the registry posted them.

Registry data comes from ClinicalTrials.gov. Study results come from studies, not from the registry. How PepBank works

Studies15

Studies that cite this trial.

Studies with results

11 studies on this page

Indexing hint: Randomized controlled trial · 2026

3 results

Dulaglutide and neurodegeneration biomarkers: REWIND post hoc analysis.

Wilson et al. 2026Alzheimer's & dementia : the journal of the Alzheimer's Associationcited by 1

PMID 41988866PMC13084528DOI 10.1002/alz.71391PUB-41988866

CC BY3 results
Download PDFSee results (3)

Indexing hint: Meta-analysis (pooled) · 2025

15 results

Glucagon-like peptide 1 (GLP-1) receptor agonists for people with chronic kidney disease and diabetes.

Natale et al. 2025The Cochrane database of systematic reviewscited by 8

PMID 39963952PMC11834151DOI 10.1002/14651858.cd015849.pub2PUB-39963952

Rights unknown15 results
Source linkSee results (15)

Indexing hint: Randomized controlled trial · 2023

6 results

Biomarker Changes Associated With Both Dulaglutide and Cardiovascular Events in the REWIND Randomized Controlled Trial: A Nested Case-Control Post Hoc Analysis.

Gerstein et al. 2023Diabetes carecited by 10

PMID 36897834DOI 10.2337/dc22-2397PUB-36897834

Full text at the publisher6 results
Publisher pageSee results (6)

Indexing hint: Randomized controlled trial · 2022

5 results

HbA1c Reduction in Dulaglutide-Treated Patients Irrespective of Duration of Diabetes, Microvascular Disease, and BMI: A Post Hoc Analysis From the REWIND Trial.

Kwan et al. 2022Diabetes carecited by 6

PMID 35043140PMC8918189DOI 10.2337/dc21-1160PUB-35043140

Rights unknown5 results
Source linkSee results (5)

PubMed tag: none · 2022

3 results

Efficacy and safety outcomes of dulaglutide by baseline HbA1c: A post hoc analysis of the REWIND trial.

Franek et al. 2022Diabetes, obesity & metabolismcited by 6

PMID 35546279PMC9543284DOI 10.1111/dom.14760PUB-35546279

Free to read · publisher termsCC BY-NC-ND3 results
Read at sourceSee results (3)

Indexing hint: Randomized controlled trial · 2021

8 results

Efficacy and Safety of Dulaglutide in Older Patients: A post hoc Analysis of the REWIND trial.

Riddle et al. 2021The Journal of clinical endocrinology and metabolismcited by 20

PMID 33537745PMC8063250DOI 10.1210/clinem/dgab065PUB-33537745

Free to read · publisher termsCC BY-NC-ND8 results
Read at sourceSee results (8)

Indexing hint: Randomized controlled trial · 2021

8 results

Exploring potential mediators of the cardiovascular benefit of dulaglutide in type 2 diabetes patients in REWIND.

Konig et al. 2021Cardiovascular diabetologycited by 51

PMID 34563178PMC8466679DOI 10.1186/s12933-021-01386-4PUB-34563178

CC BY8 results
Download PDFSee results (8)

Indexing hint: Randomized controlled trial · 2020

6 results

The effect of dulaglutide on stroke: an exploratory analysis of the REWIND trial.

Gerstein et al. 2020The lancet. Diabetes & endocrinologycited by 96

PMID 31924562DOI 10.1016/s2213-8587(19)30423-1PUB-31924562

Full text at the publisher6 results
Publisher pageSee results (6)

Indexing hint: Randomized controlled trial · 2020

2 results

Total cardiovascular or fatal events in people with type 2 diabetes and cardiovascular risk factors treated with dulaglutide in the REWIND trail: a post hoc analysis.

Dagenais et al. 2020Cardiovascular diabetologycited by 27

PMID 33239067PMC7690176DOI 10.1186/s12933-020-01179-1PUB-33239067

CC BY2 results
Download PDFSee results (2)

Indexing hint: Randomized controlled trial · 2019

4 results

Dulaglutide and renal outcomes in type 2 diabetes: an exploratory analysis of the REWIND randomised, placebo-controlled trial.

Gerstein et al. 2019Lancet (London, England)cited by 467

PMID 31189509DOI 10.1016/s0140-6736(19)31150-xPUB-31189509

Full text at the publisher4 results
Publisher pageSee results (4)

Indexing hint: Randomized controlled trial · 2019

3 results

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

Gerstein et al. 2019Lancet (London, England)cited by 2,264

PMID 31189511DOI 10.1016/s0140-6736(19)31149-3PUB-31189511

Full text at the publisher3 results
Publisher pageSee results (3)

PubMed tag: none · 2018

Design and baseline characteristics of participants in the Researching cardiovascular Events with a Weekly INcretin in Diabetes (REWIND) trial on the cardiovascular effects of dulaglutide.

Gerstein et al. 2018Diabetes, obesity & metabolismcited by 129

PMID 28573765DOI 10.1111/dom.13028PUB-28573765

Rights unknown
Source link

More studies

3 studies on this page

Indexing hint: Randomized controlled trial · 2021

Corrected

Erectile function in men with type 2 diabetes treated with dulaglutide: an exploratory analysis of the REWIND placebo-controlled randomised trial.

Bajaj et al. 2021The lancet. Diabetes & endocrinologycited by 41

PMID 34153269DOI 10.1016/s2213-8587(21)00115-7PUB-34153269

Full text at the publisher
Publisher pageRead the notice

Indexing hint: Randomized controlled trial · 2020

Corrected

Effect of dulaglutide on cognitive impairment in type 2 diabetes: an exploratory analysis of the REWIND trial.

Cukierman-Yaffe et al. 2020The Lancet. Neurologycited by 242

PMID 32562683DOI 10.1016/s1474-4422(20)30173-3PUB-32562683

Full text at the publisher
Publisher pageRead the notice

PubMed tag: none · 2018

Generalizability of glucagon-like peptide-1 receptor agonist cardiovascular outcome trials enrollment criteria to the US type 2 diabetes population.

Wittbrodt et al. 2018The American journal of managed carecited by 21

PMID 29693361PUB-29693361

Full text at the publisher
Publisher page

Other registry references

References listed at the registry that are not in PepBank. They link to PubMed.

  • DerivedFerrannini G, Maldonado JM, Raha S, Rao-Melacini P, Khatun R, Atisso C, Shurzinske L, Gerstein HC, Ryden L, Bethel MA. Gender differences in cardiovascular risk, treatment, and outcomes: a post hoc analysis from the REWIND trial. Scand Cardiovasc J. 2023 Dec;57(1):2166101. doi: 10.1080/14017431.2023.2166101. PMID 36723445
  • DerivedGerstein HC, Ramasundarahettige C, Avezum A, Basile J, Conget I, Cushman WC, Dagenais GR, Franek E, Lakshmanan M, Lanas F, Leiter LA, Pogosova N, Probstfield J, Raubenheimer PJ, Riddle M, Shaw J, Sheu WH, Temelkova-Kurktschiev T, Turfanda I, Xavier D. A novel kidney disease index reflecting both the albumin-to-creatinine ratio and estimated glomerular filtration rate, predicted cardiovascular and kidney outcomes in type 2 diabetes. Cardiovasc Diabetol. 2022 Aug 22;21(1):158. doi: 10.1186/s12933-022-01594-6. PMID 35996147
  • DerivedCukierman-Yaffe T, Gerstein HC, Basile J, Bethel MA, Cardona-Munoz EG, Conget I, Dagenais G, Franek E, Hall S, Hancu N, Jansky P, Lakshmanan M, Lanas F, Leiter LA, Lopez-Jaramillo P, Pirags V, Pogosova N, Probstfield J, Rao-Melacini P, Ramasundarahettige C, Raubenheimer PJ, Riddle MC, Ryden L, Shaw JE, Sheu WH, Temelkova-Kurktschiev T. Novel Indices of Cognitive Impairment and Incident Cardiovascular Outcomes in the REWIND Trial. J Clin Endocrinol Metab. 2022 Jul 14;107(8):e3448-e3454. doi: 10.1210/clinem/dgac200. PMID 35446415

Eligibility

Who could join, as posted.

Sex
All
Age
from 50 Years
Healthy volunteers
Not accepted
Inclusion and exclusion criteria, as posted
Inclusion Criteria: * Type 2 diabetes with Hemoglobin A1c equal to or less than 9.5% (equal to or less than 81 mmol/mol) * Anti-hyperglycemic drug naive or treated with up to 2 oral hyperglycemic drugs with or without a glucagon-like peptide-1analog or basal insulin, or basal insulin alone * On stable antihyperglycemic regimen for at least 3 months * Age equal to or greater than 50 years with established clinical vascular disease, or age equal to or greater than 55 years and subclinical vascular disease or age equal to or greater than 60 years and at least 2 or more cardiovascular risk factors Exclusion Criteria: * Uncontrolled diabetes requiring immediate therapy * History of severe hypoglycemia in past year * Acute coronary or cerebrovascular event within past 2 months * Planned or anticipated revascularization procedure * History of pancreatitis, hepatic insufficiency , chronic renal failure or of C-cell thyroid disorder * Pregnancy or planned pregnancy during the trial period * Completed or withdrawn from any study investigating dulaglutide

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