REWIND

CompletedPhase 3Results posted

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

The Effect of Dulaglutide on Major Cardiovascular Events in Patients With Type 2 Diabetes: Researching Cardiovascular Events With a Weekly INcretin in Diabetes (REWIND)

Lead sponsor

Eli Lilly and Company

Asset

Dulaglutide

Subcutaneous · GLP-1 agonist

Listed sites

300

Recruiting sites

—

Enrollment

9,901

actual

Study population

Cardiovascular disease, Type 2 diabetes

Key I/E criterion

•HbA1c ≤9.5%

Primary endpoint

•3-point MACE (Cardiovascular death, Non-fatal MI, Non-fatal stroke)

Footprint

Where this trial recruits

Site locations as reported to ClinicalTrials.gov. Site count is not enrollment count; per-site enrollment is not available from source.

Identifiers

Registered as

NCT IDNCT01394952

Org study ID13438

Secondary IDH9X-MC-GBDJEli Lilly and Company

Timeline

Milestones

Study first posted2011-07-15estimated

Study start2011-07-22actual

Primary completion2018-08-21actual

Study completion2018-08-21actual

Last update posted2019-10-08actual

Results first posted2019-10-08actual

Assets

Investigational agents

Dulaglutide

Study populations

Who this study enrolls

Cardiovascular diseaseType 2 diabetes

Eligibility

Who can enroll

Minimum age50 Years

SexAll

Healthy volunteersNot accepted

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•Completed or withdrawn from any study investigating dulaglutide

Endpoints (12)

What's being measured

Protocol endpoints and posted registry outcome measures, grouped into outcome categories. Composite endpoints show their component event types. Standard codes (LOINC, SNOMED CT) are shown where available.

Coverage by outcome category

Cardiovascular outcomes

Heart failure

Renal / kidney

Cardiovascular outcomes

8 endpoints

Primary/registry result

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)

3-point MACE

time to event, event

componentsCardiovascular death, Non-fatal MI, Non-fatal stroke

Posted result

Group	Value (count_of_participants), Participants	95% CI
Placebo	663	—
Dulaglutide	594	—

Hazard Ratio (HR)0.8895.33% CI0.79 – 0.99p0.026Regression, Cox

Primary CV endpoint

Primary/protocol endpoint

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

3-point MACE

time to event, event

componentsCardiovascular death, Non-fatal MI, Non-fatal stroke

Secondary/registry result

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)

3-point MACE

time to event, event

Posted result

Group	Value (count_of_participants), Participants	95% CI
PlaceboDeath from CV causes	346	—
Nonfatal MI	212	—
Nonfatal stroke	175	—
DulaglutideDeath from CV causes	317	—
Nonfatal MI	205	—
Nonfatal stroke	135	—

Hazard Ratio (HR)0.9195% CI0.78 – 1.06p0.211Regression, Cox

Death from CV causes

Hazard Ratio (HR)0.9695% CI0.79 – 1.16p0.652Regression, Cox

Nonfatal MI

Hazard Ratio (HR)0.7695% CI0.61 – 0.95p0.017Regression, Cox

Nonfatal stroke

Secondary/registry result

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)

All-cause death

time to event, event

SNOMED 419620001

Posted result

Group	Value (count_of_participants), Participants	95% CI
Placebo	592	—
Dulaglutide	536	—

Hazard Ratio (HR)0.9095% CI0.80 – 1.01p0.067Regression, Cox

Time to all cause mortality

Secondary/registry result

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)

Unstable angina hospitalization

time to event, event

Posted result

Group	Value (count_of_participants), Participants	95% CI
Placebo	77	—
Dulaglutide	88	—

Hazard Ratio (HR)1.1495% CI0.84 – 1.54p0.413Regression, Cox

Hospitalization for unstable angina

Secondary/protocol endpoint

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)

time to event, event

Secondary/protocol endpoint

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)

All-cause death

time to event, event

SNOMED 419620001

Secondary/protocol endpoint

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)

Unstable angina hospitalization

time to event, event

Heart failure

2 endpoints

Secondary/registry result

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)

Heart-failure composite

time to event, event

componentsHeart-failure hospitalization, Urgent heart-failure visit

SNOMED 84114007

Posted result

Group	Value (count_of_participants), Participants	95% CI
Placebo	226	—
Dulaglutide	213	—

Hazard Ratio (HR)0.9395% CI0.77 – 1.12p0.456Regression, Cox

Heart failure requiring hospitalization or an urgent heart failure clinic visit

Secondary/protocol endpoint

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)

Heart-failure composite

time to event, event

componentsHeart-failure hospitalization, Urgent heart-failure visit

SNOMED 84114007

Renal / kidney

2 endpoints

Secondary/registry result/low confidence

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)

time to event, event

componentsuACR, change, eGFR, change, Kidney-replacement therapy

Posted result

Group	Value (count_of_participants), Participants	95% CI
Placebo	1241	—
Dulaglutide	1099	—

Hazard Ratio (HR)0.8695% CI0.79 – 0.93p<0.001Regression, Cox

microvascular endpoint

Secondary/protocol endpoint

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)

Custom renal composite

time to event, event

componentsuACR, change, eGFR, change, Kidney-replacement therapy

Publications (19)

Bibliography

Records linked to this trial through ClinicalTrials.gov references, PubMed NCT search, and curated study seeds. 'Canonical' marks design/result papers; others are registry references or candidates.

Registry references + supporting bibliography

Calculating cost per event avoided using a composite number needed to treat.
Journal of medical economics2026 Dec (month)PMID41562647doi:10.1080/13696998.2026.2615606via pubmed nct search
Dulaglutide and neurodegeneration biomarkers: REWIND post hoc analysis.
Alzheimer's & dementia : the journal of the Alzheimer's Association2026 Apr (month)PMID41988866doi:10.1002/alz.71391via clinicaltrials gov reference derived + pubmed nct search
Glucagon-like peptide 1 (GLP-1) receptor agonists for people with chronic kidney disease and diabetes.
The Cochrane database of systematic reviews2025 Feb 18PMID39963952doi:10.1002/14651858.CD015849.pub2via clinicaltrials gov reference derived + pubmed nct search
Gender differences in cardiovascular risk, treatment, and outcomes: a post hoc analysis from the REWIND trial.
Scandinavian cardiovascular journal : SCJ2023 Dec (month)PMID36723445doi:10.1080/14017431.2023.2166101via clinicaltrials gov reference derived + pubmed nct search
Biomarker Changes Associated With Both Dulaglutide and Cardiovascular Events in the REWIND Randomized Controlled Trial: A Nested Case-Control Post Hoc Analysis.
Diabetes care2023 May 1PMID36897834doi:10.2337/dc22-2397via clinicaltrials gov reference derived + pubmed nct search
Efficacy and safety outcomes of dulaglutide by baseline HbA1c: A post hoc analysis of the REWIND trial.
Diabetes, obesity & metabolism2022 Sep (month)PMID35546279doi:10.1111/dom.14760via clinicaltrials gov reference derived + pubmed nct search
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.
Cardiovascular diabetology2022 Aug 22PMID35996147doi:10.1186/s12933-022-01594-6via clinicaltrials gov reference derived + pubmed nct search
Novel Indices of Cognitive Impairment and Incident Cardiovascular Outcomes in the REWIND Trial.
The Journal of clinical endocrinology and metabolism2022 Jul 14PMID35446415doi:10.1210/clinem/dgac200via clinicaltrials gov reference derived + pubmed nct search
HbA1c Reduction in Dulaglutide-Treated Patients Irrespective of Duration of Diabetes, Microvascular Disease, and BMI: A Post Hoc Analysis From the REWIND Trial.
Diabetes care2022 Mar 1PMID35043140doi:10.2337/dc21-1160via clinicaltrials gov reference derived + pubmed nct search
Exploring potential mediators of the cardiovascular benefit of dulaglutide in type 2 diabetes patients in REWIND.
Cardiovascular diabetology2021 Sep 25PMID34563178doi:10.1186/s12933-021-01386-4via clinicaltrials gov reference derived + pubmed nct search
Erectile function in men with type 2 diabetes treated with dulaglutide: an exploratory analysis of the REWIND placebo-controlled randomised trial.
The lancet. Diabetes & endocrinology2021 Aug (month)PMID34153269doi:10.1016/S2213-8587(21)00115-7via clinicaltrials gov reference derived + pubmed nct search
Efficacy and Safety of Dulaglutide in Older Patients: A post hoc Analysis of the REWIND trial.
The Journal of clinical endocrinology and metabolism2021 Apr 23PMID33537745doi:10.1210/clinem/dgab065via clinicaltrials gov reference derived + pubmed nct search
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.
Cardiovascular diabetology2020 Nov 25PMID33239067doi:10.1186/s12933-020-01179-1via clinicaltrials gov reference derived + pubmed nct search
Effect of dulaglutide on cognitive impairment in type 2 diabetes: an exploratory analysis of the REWIND trial.
The Lancet. Neurology2020 Jul (month)PMID32562683doi:10.1016/S1474-4422(20)30173-3via clinicaltrials gov reference derived + pubmed nct search
The effect of dulaglutide on stroke: an exploratory analysis of the REWIND trial.
The lancet. Diabetes & endocrinology2020 Feb (month)PMID31924562doi:10.1016/S2213-8587(19)30423-1via clinicaltrials gov reference derived + pubmed nct search
Dulaglutide and renal outcomes in type 2 diabetes: an exploratory analysis of the REWIND randomised, placebo-controlled trial.
Lancet (London, England)2019 Jul 13PMID31189509doi:10.1016/S0140-6736(19)31150-Xvia clinicaltrials gov reference derived + pubmed nct search
Dulaglutide and cardiovascular outcomes in type 2 diabetes (REWIND): a double-blind, randomised placebo-controlled trial.
Lancet (London, England)2019 Jul 13PMID31189511doi:10.1016/S0140-6736(19)31149-3via clinicaltrials gov reference derived + pubmed nct search
Generalizability of glucagon-like peptide-1 receptor agonist cardiovascular outcome trials enrollment criteria to the US type 2 diabetes population.
The American journal of managed care2018 Apr (month)PMID29693361via clinicaltrials gov reference derived + pubmed nct search
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.
Diabetes, obesity & metabolism2018 Jan (month)PMID28573765doi:10.1111/dom.13028via clinicaltrials gov reference derived + pubmed nct search

Provenance

Sources

Trial identity, design, statusClinicalTrials.gov API v2

Snapshot dateJuly 1, 2026

Endpoint classificationDelfa endpoint taxonomy v2 (May 13, 2026)

Results tableClinicalTrials.gov results section

Trial facts come from public ClinicalTrials.gov records. Endpoint categories are Delfa's classification of those records, not a ClinicalTrials.gov field. All figures reflect the July 1, 2026 snapshot.