Study S000147

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

Included trial: extracted data ClinicalTrials.gov record Study Protocol (PDF)Statistical Analysis Plan (PDF)

Registration

Registration: NCT01394952
Acronym: REWIND
Study type: INTERVENTIONAL
Allocation: RANDOMIZED
Phase: PHASE3
Masking: DOUBLE
Status: COMPLETED
Enrollment: 9901
Start: 2011-07-22
Primary completion: 2018-08-21
Lead sponsor: Eli Lilly and Company
Conditions: Cardiovascular Disease; Diabetes Mellitus, Type 2
Interventions: DRUG:Dulaglutide; DRUG:Placebo
Results posted: TRUE
Individual participant data sharing: YES
Secondary identifiers: OTHER:H9X-MC-GBDJ

Registered primary outcomes

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

Linked records (21)

Automatic links, confirmed or rejected during screening. A record citing this registration may be a secondary analysis, a commentary or a review that mentions the trial.

Record	Title	Year	Design	Identifiers	Link basis
R0009863	Calculating cost per event avoided using a composite number needed to treat. Toliver J, Journal of medical economics	2026	Other	PMID 41562647 DOI	cites ClinicalTrials.gov:NCT01394952
R0012751	Dulaglutide and neurodegeneration biomarkers: REWIND post hoc analysis. Wilson JM, Alzheimer's & dementia : the journal of the Alzheimer's Association	2026	Other trial	PMID 41988866 DOI	cites ClinicalTrials.gov:NCT01394952; registry reference DERIVED:41988866
R0010237	Glucagon-like peptide 1 (GLP-1) receptor agonists for people with chronic kidney disease and diabetes. Natale P, The Cochrane database of systematic reviews	2025	Systematic review	PMID 39963952 DOI	cites ClinicalTrials.gov:NCT01394952; registry reference DERIVED:39963952
R0008612	Biomarker Changes Associated With Both Dulaglutide and Cardiovascular Events in the REWIND Randomized Controlled Trial: A Nested Case-Control Post Hoc Analysis. Gerstein HC, Diabetes care	2023	Randomized trial	PMID 36897834 DOI	cites ClinicalTrials.gov:NCT01394952; registry reference DERIVED:36897834
R0021370	HbA1c Reduction in Dulaglutide-Treated Patients Irrespective of Duration of Diabetes, Microvascular Disease, and BMI: A Post Hoc Analysis From the REWIND Trial. Kwan AYM, Diabetes care	2022	Other trial	PMID 35043140 DOI	cites ClinicalTrials.gov:NCT01394952; registry reference DERIVED:35043140
R0021955	Efficacy and safety outcomes of dulaglutide by baseline HbA1c: A post hoc analysis of the REWIND trial. Franek E, Diabetes, obesity & metabolism	2022	Other trial	PMID 35546279 DOI	cites ClinicalTrials.gov:NCT01394952; registry reference DERIVED:35546279
R0038401	731-P: Metabolite Biomarkers and Cardiovascular Events in REWIND: A Post Hoc Analysis Valentina Pirro, Diabetes	2022	Nonrandomized study	DOI	cites ClinicalTrials.gov:NCT01394952
R0018616	Erectile function in men with type 2 diabetes treated with dulaglutide: an exploratory analysis of the REWIND placebo-controlled randomised trial. Bajaj HS, The lancet. Diabetes & endocrinology	2021	Randomized trial	PMID 34153269 DOI	cites ClinicalTrials.gov:NCT01394952; registry reference DERIVED:34153269
R0021858	Exploring potential mediators of the cardiovascular benefit of dulaglutide in type 2 diabetes patients in REWIND. Konig M, Cardiovascular diabetology	2021	Other trial	PMID 34563178 DOI	cites ClinicalTrials.gov:NCT01394952; registry reference DERIVED:34563178
R0022641	Efficacy and Safety of Dulaglutide in Older Patients: A post hoc Analysis of the REWIND trial. Riddle MC, The Journal of clinical endocrinology and metabolism	2021	Randomized trial	PMID 33537745 DOI	cites ClinicalTrials.gov:NCT01394952; registry reference DERIVED:33537745
R0042347	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 GR Dagenais, Figshare	2021	Randomized trial	DOI	cites ClinicalTrials.gov:NCT01394952
R0012279	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 GR, Cardiovascular diabetology	2020	Randomized trial	PMID 33239067 DOI	cites ClinicalTrials.gov:NCT01394952; registry reference DERIVED:33239067
R0020309	Effect of dulaglutide on cognitive impairment in type 2 diabetes: an exploratory analysis of the REWIND trial. Cukierman-Yaffe T, The Lancet. Neurology	2020	Randomized trial	PMID 32562683 DOI	cites ClinicalTrials.gov:NCT01394952; registry reference DERIVED:32562683
R0021071	The effect of dulaglutide on stroke: an exploratory analysis of the REWIND trial. Gerstein HC, The lancet. Diabetes & endocrinology	2020	Randomized trial	PMID 31924562 DOI	cites ClinicalTrials.gov:NCT01394952; registry reference DERIVED:31924562
R0048079	Abstract 15586: Burden of Cardiovascular or Fatal Outcomes in People With Type 2 Diabetes and Cardiovascular Risk Factors Treated With Dulaglutide a Post Hoc Analysis From the Rewind Trial Gilles R. Dagenais, Circulation	2020	Other trial	DOI	cites ClinicalTrials.gov:NCT01394952
R0018537	Dulaglutide and cardiovascular outcomes in type 2 diabetes (REWIND): a double-blind, randomised placebo-controlled trial. Gerstein HC, Lancet (London, England)	2019	Randomized trial	PMID 31189511 DOI	cites ClinicalTrials.gov:NCT01394952; registry reference DERIVED:31189511
R0018694	Dulaglutide and renal outcomes in type 2 diabetes: an exploratory analysis of the REWIND randomised, placebo-controlled trial. Gerstein HC, Lancet (London, England)	2019	Randomized trial	PMID 31189509 DOI	cites ClinicalTrials.gov:NCT01394952; registry reference DERIVED:31189509
R0007117	Generalizability of glucagon-like peptide-1 receptor agonist cardiovascular outcome trials enrollment criteria to the US type 2 diabetes population. Wittbrodt ET, The American journal of managed care	2018	Nonrandomized study	PMID 29693361	cites ClinicalTrials.gov:NCT01394952; registry reference DERIVED:29693361
R0021448	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 HC, Diabetes, obesity & metabolism	2018	Randomized trial	PMID 28573765 DOI	cites ClinicalTrials.gov:NCT01394952; registry reference DERIVED:28573765
R0049736	Implications of cardiovascular outcome trials with injectable antidiabetic agents Richard E. Pratley, Journal of Diabetes	2018	Randomized trial	PMID 29971941 DOI	cites ClinicalTrials.gov:NCT01394952
R0043293	The emergence of cardiodiabetology Paul D. Rosenblit, Cardiovascular Endocrinology	2017	Randomized trial	PMID 31646112 DOI	cites ClinicalTrials.gov:NCT01394952