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

Official Title

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

Status

Completed

Overview

The REWIND trial recruited 9901 middle-aged people with type 2 diabetes, a mean HbA1c of 7.3% and additional cardiovascular risk factors, and allocated them to weekly subcutaneous injections of either dulaglutide (1.5 mg) or placebo. During more than five years of follow-up, dulaglutide reduced the risk of cardiovascular events in people with and without prior cardiovascular disease.

Visit phri.ca/rewind.

Download the REWIND ADA 2019 Gerstein PHRI presentation slides.

Study Design

Phase 3, event-driven, multicenter, international, randomized, double-blind, placebo-controlled, parallel study

Primary Endpoint

Time to first occurrence (after randomization) of the composite endpoint of death from CV causes, nonfatal MI, or nonfatal stroke.

Number of Patients

9901

Number of Sites

371

Number of Countries

24

Study Period

2010–2019

Principal Investigator

Hertzel Gerstein

Program Manager

Tara McCready

Research Coordinator

Stephanie Hall

Collaborators

Eli Lilly

Key Publications

Dulaglutide and cardiovascular outcomes in type 2 diabetes (REWIND): a double-blind, randomised placebo-controlled trial. Gerstein HC, Colhoun HM, Dagenais GR, Diaz R, Lakshmanan M, Pais P, Probstfield J, Riesmeyer JS, Riddle MC, Rydén L, Xavier D, Atisso CM, Dyal L, Hall S, Rao-Melacini P, Wong G, Avezum A, Basile J, Chung N, Conget I, Cushman WC, Franek E, Hancu N, Hanefeld M, Holt S, Jansky P, Keltai M, Lanas F, Leiter LA, Lopez-Jaramillo P, Cardona Munoz EG, Pirags V, Pogosova N, Raubenheimer PJ, Shaw JE, Sheu WH, Temelkova-Kurktschiev T; REWIND Investigators.Lancet. 2019 Jun 7. pii: S0140-6736(19)31149-3. doi: 10.1016/S0140-6736(19)31149-3. [Epub ahead of print] PMID: 31189511

Dulaglutide and renal outcomes in type 2 diabetes: an exploratory analysis of the REWIND randomised, placebo-controlled trial.Gerstein HC, Colhoun HM, Dagenais GR, Diaz R, Lakshmanan M, Pais P, Probstfield J, Botros FT, Riddle MC, Rydén L, Xavier D, Atisso CM, Dyal L, Hall S, Rao-Melacini P, Wong G, Avezum A, Basile J, Chung N, Conget I, Cushman WC, Franek E, Hancu N, Hanefeld M, Holt S, Jansky P, Keltai M, Lanas F, Leiter LA, Lopez-Jaramillo P, Cardona Munoz EG, Pirags V, Pogosova N, Raubenheimer PJ, Shaw JE, Sheu WH, Temelkova-Kurktschiev T; REWIND Investigators. Lancet. 2019 Jun 7. pii: S0140-6736(19)31150-X. doi: 10.1016/S0140-6736(19)31150-X. [Epub ahead of print] PMID: 31189509.

Generalizability of glucagon-like peptide-1 receptor agonist cardiovascular outcome trials to the overall type 2 diabetes population in the United States.Boye KS, Riddle MC, Gerstein HC, Mody R, Garcia-Perez LE, Karanikas CA, Lage MJ, Riesmeyer JS, Lakshmanan MC. Diabetes Obes Metab. 2019 Jun;21(6):1299-1304. doi: 10.1111/dom.13649. Epub 2019 Mar 12. PMID: 30714309

Generalizability of results from the recent FDA-guided cardiovascular outcomes trials to a representative population with Type 2 Diabetes attending primary care clinics. Vinagre I, Gerstein H, Vinals C, Conget I. Endocrinol Diabetes Nutr. Epub 2019. PMID: 30890422

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, Colhoun HM, Dagenais GR, Diaz R, Lakshmanan M, Pais P, Probstfield J, Riddle MC, Rydén L, Xavier D, Atisso CM, Avezum A, Basile J, Chung N, Conget I, Cushman WC, Franek E, Hancu N, Hanefeld M, Holt S, Jansky P, Keltai M, Lanas F, Leiter LA, Lopez-Jaramillo P, Cardona-Munoz EG, Pirags V, Pogosova N, Raubenheimer PJ, Shaw J, Sheu WH, Temelkova-Kurktschiev T; REWIND Trial Investigators. Diabetes Obes Metab. 2018 Jan;20(1):42-49. doi: 10.1111/dom.13028. Epub 2017 Jul 14. PMID: 28573765