Phase 3
Completed N=9,901
Researching Cardiovascular Events With a Weekly Incretin in Diabetes (REWIND)
Source: ClinicalTrials.gov NCT01394952 ↗Enrolled (actual)
9,901
Serious AEs
40.8%
Results posted
Oct 2019
Primary outcomePrimary: 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) — 663; 594 Participants — p=0.026
◆ Published Evidence
Emerging
15citations · ~4 / year
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.
Summary
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.
Linked Publications (5)
-
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.
-
Gender differences in cardiovascular risk, treatment, and outcomes: a post hoc analysis from the REWIND trial.
-
Biomarker Changes Associated With Both Dulaglutide and Cardiovascular Events in the REWIND Randomized Controlled Trial: A Nested Case-Control Post Hoc Analysis.
-
Glucagon-like peptide 1 (GLP-1) receptor agonists for people with chronic kidney disease and diabetes.
-
Dulaglutide and neurodegeneration biomarkers: REWIND post hoc analysis.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY 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) |
663; 594 | 0.026 sig |
| SECONDARY 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 |
346; 317; 212; 205; 175; 135 | 0.211 |
| SECONDARY Number of Participants Who Experienced an Event for Time to All-cause Mortality |
592; 536 | 0.067 |
| SECONDARY Number of Participants Who Experienced an Event for Time to First Occurrence After Randomization of the Composite Microvascular Endpoint |
1241; 1099 | <0.001 sig |
| SECONDARY 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 |
226; 213 | 0.456 |
| SECONDARY Number of Participants Who Experienced an Event for Time to First Occurrence After Randomization of First Hospitalization for Unstable Angina |
77; 88 | 0.413 |
Eligibility Criteria
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
Data sourced from ClinicalTrials.gov (NCT01394952) and the linked publication. Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.