Primary outcome
What REWIND measured first
| Placebon=4,952 | Dulaglutiden=4,949 |
|---|---|
| 663 | 594 |
Phase 3 · Dulaglutide
REWIND trial results
The Effect of Dulaglutide on Major Cardiovascular Events in Patients With Type 2 Diabetes: Researching Cardiovascular Events With a Weekly INcretin in Diabetes (REWIND)
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) (Participants), From randomization to first occurrence or death from any cause or study completion (Median Follow-Up of 5.4 Years). Placebo: 663; Dulaglutide: 594.
- Participants
- 9,901
- Status
- completed
- Completed
- 2018-08-21
- Sponsor
- Eli Lilly and Company
As posted on ClinicalTrials.gov (NCT01394952), updated at source Oct 8, 2019. Read again whenever the registry updates it. Registry figures can differ from a published paper, which may use another analysis.
Side effects by arm
Side effects in REWIND
Percent of participants affected, From Randomization to Study Completion (Up to 7 Years). The most common events the registry lists.
| Event | Placebo | Dulaglutide |
|---|---|---|
| Any serious event | 41.3% | 40.3% |
| Nausea | 5.4% | 14.9% |
| Diarrhoea | 8.8% | 13.5% |
| Nasopharyngitis | 10.8% | 11.4% |
| Urinary tract infection | 10.4% | 11% |
| Back pain | 8.4% | 9% |
| Hypertension | 8.7% | 7% |
| Bronchitis | 8.5% | 8.3% |
| Hypoglycaemia | 7.2% | 8.4% |
| Influenza | 8.2% | 7.5% |
| Upper respiratory tract infection | 8.2% | 7.4% |
| Arthralgia | 7.9% | 7.5% |
| Cataract | 7.4% | 7.3% |
| Constipation | 4.2% | 7.3% |
| Osteoarthritis | 6.4% | 6.7% |
| Vomiting | 3.1% | 6.6% |
| Decreased appetite | 2.1% | 6.6% |
| Headache | 5.8% | 6.6% |
| Hyperglycaemia | 6.4% | 3.2% |
| Dizziness | 6% | 6.4% |
| Dyspepsia | 3% | 5.9% |
| Pain in extremity | 5% | 5.3% |
| Benign prostatic hyperplasia | 5.1% | 5.3% |
| Microalbuminuria | 5.2% | 4.7% |
| Cough | 5.2% | 4.8% |
Secondary outcomes
What else it measured
| Measure | Placebon=4,952 | Dulaglutiden=4,949 |
|---|---|---|
| Death from CV causes | 346 | 317 |
| Nonfatal MI | 212 | 205 |
| Nonfatal stroke | 175 | 135 |
| Placebon=4,952 | Dulaglutiden=4,949 |
|---|---|
| 592 | 536 |
| Placebon=4,952 | Dulaglutiden=4,949 |
|---|---|
| 1241 | 1099 |
| Placebon=4,952 | Dulaglutiden=4,949 |
|---|---|
| 226 | 213 |
| Placebon=4,952 | Dulaglutiden=4,949 |
|---|---|
| 77 | 88 |
The trial
How REWIND was run
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.
- 1.5 mg Dulaglutide: Administered once weekly, subcutaneously
- Placebo: Administered once weekly, subcutaneously
Who could join the trial
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
Published papers
Papers from REWIND
- Wilson JM, Dage JL, Qian HR, Irelan CL, Crowder HS, Duffin KL, Mintun M, Brooks DA, Gerstein HC, Bethel MA. Dulaglutide and neurodegeneration biomarkers: REWIND post hoc analysis. Alzheimers Dement. 2026 Apr;22(4):e71391. doi: 10.1002/alz.71391.
- Natale P, Green SC, Tunnicliffe DJ, Pellegrino G, Toyama T, Strippoli GF. Glucagon-like peptide 1 (GLP-1) receptor agonists for people with chronic kidney disease and diabetes. Cochrane Database Syst Rev. 2025 Feb 18;2(2):CD015849. doi: 10.1002/14651858.CD015849.pub2.
- Gerstein HC, Lee SF, Pare G, Bethel MA, Colhoun HM, Hoover A, Lakshmanan M, Lin Y, Pirro V, Qian HR, Ruotolo G, Ryden L, Wilson JM, Duffin KL. Biomarker Changes Associated With Both Dulaglutide and Cardiovascular Events in the REWIND Randomized Controlled Trial: A Nested Case-Control Post Hoc Analysis. Diabetes Care. 2023 May 1;46(5):1046-1051. doi: 10.2337/dc22-2397.
- Ferrannini 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.
- Gerstein 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:...
- Franek E, Gerstein HC, Riddle MC, Nicolay C, Hickey A, Botros FT, Loo LS. Efficacy and safety outcomes of dulaglutide by baseline HbA1c: A post hoc analysis of the REWIND trial. Diabetes Obes Metab. 2022 Sep;24(9):1753-1761. doi: 10.1111/dom.14760. Epub 2022 May 30.
- Cukierman-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:...
- Kwan AYM, Gerstein HC, Basile J, Xavier D, Maldonado JM, Raha S, Konig M. HbA1c Reduction in Dulaglutide-Treated Patients Irrespective of Duration of Diabetes, Microvascular Disease, and BMI: A Post Hoc Analysis From the REWIND Trial. Diabetes Care. 2022 Mar 1;45(3):547-554. doi: 10.2337/dc21-1160.
- Konig M, Riddle MC, Colhoun HM, Branch KR, Atisso CM, Lakshmanan MC, Mody R, Raha S, Gerstein HC. Exploring potential mediators of the cardiovascular benefit of dulaglutide in type 2 diabetes patients in REWIND. Cardiovasc Diabetol. 2021 Sep 25;20(1):194. doi: 10.1186/s12933-021-01386-4.
- Bajaj HS, Gerstein HC, Rao-Melacini P, Basile J, Colhoun H, Conget I, Cushman WC, Dagenais GR, Franek E, Hanefeld M, Keltai M, Lakshmanan M, Lanas F, Leiter LA, Lopez-Jaramillo P, Pirags V, Pogosova N, Probstfield J, Raubenheimer P, Ryden L, Shaw JE, Sheu WH, Xavier D. Erectile function in men with type 2 diabetes treated with dulaglutide: an exploratory analysis of the REWIND placebo-controlled randomised trial. Lancet Diabetes Endocrinol. 2021 Aug;9(8):484-490. doi:...
- Riddle MC, Gerstein HC, Xavier D, Cushman WC, Leiter LA, Raubenheimer PJ, Atisso CM, Raha S, Varnado OJ, Konig M, Lakshmanan M, Franek E. Efficacy and Safety of Dulaglutide in Older Patients: A post hoc Analysis of the REWIND trial. J Clin Endocrinol Metab. 2021 Apr 23;106(5):1345-1351. doi: 10.1210/clinem/dgab065.
- Dagenais GR, Ryden L, Leiter LA, Lakshmanan M, Dyal L, Probstfield JL, Atisso CM, Shaw JE, Conget I, Cushman WC, Lopez-Jaramillo P, Lanas F, Munoz EGC, Pirags V, Pogosova N, Basile J, Sheu WHH, Temelkova-Kurktschiev T, Raubenheimer PJ, Keltai M, Hall S, Pais P, Colhoun HM, Riddle MC, Gerstein HC. 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. Cardiovasc Diabetol. 2020 Nov...
Trial averages do not predict what one person will experience. Results are shown as the registry posts them, without interpretation.
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