Study Type
Interventional - Drug
completed
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.
Primary endpoint:
Time to first occurrence (after randomization) of the composite endpoint of death from CV causes, nonfatal MI, or nonfatal stroke.
Secondary endpoints:
Each component of the primary composite cardiovascular outcome, a composite clinical microvascular outcome comprising retinal or renal disease, hospitalization for unstable angina, heart failure requiring hospitalization or an urgent heart failure visit, and all-cause mortality.
During more than five years of follow-up, dulaglutide reduced the risk of cardiovascular events in people with and without prior cardiovascular disease.
Based on the results of the REWIND study, the Food and Drug Administration (FDA) in the United States, in February 2020, approved dulaglutide for reducing the risk of major adverse cardiovascular events (cardiovascular death, non-fatal myocardial infarction, or non-fatal stroke) in adults with type 2 diabetes who have multiple cardiovascular risk factors – with or without established cardiovascular disease.
REWIND_ADA 2019 - Download PDF REWIND_ADA 2019 - Download PPT SlidesStudy Design
Phase 3, randomized, double-blind, placebo-controlled, parallel
NO. of Countries
24
NO. of Sites
404
NO. of Participants
9901
Study Period
2011-2018
Sponsor
Eli Lilly
Hertzel Gerstein
Interim Executive Director; Senior Scientist
Hertzel Gerstein
Interim Executive Director; Senior Scientist
Hertzel Gerstein is PHRI’s Interim Executive Director and Senior Lead of the Diabetes Scientific Program. He is also a Professor of Medicine at McMaster University where he holds the Population Health Research Institute Chair in Diabetes; an Endocrinologist; Director of the Boris Clinic Diabetes Care and Research Program; Chair of Diabetes Clinical Trials Network Canada; and a Fellow of both the Canadian Academy of Health Sciences and the Royal Society of Canada.
Gerstein pioneered and firmly established international long-term diabetes-focused outcomes trials as the norm to support Evidence-Based Diabetes Care. Randomized trials that he designed and led have collectively included more than 90,000 people with either diabetes or prediabetes to date, and have studied and identified clinically important, life-saving diabetes therapies. These trials were supported by the US National Institute of Health, the Canadian Institutes of Health Research, other Canadian peer-review agencies, and by industry. Together, they have substantially expanded the evidence-base pertaining to the prevention, remission, and treatment of diabetes and its consequences, and some of their findings have provided the evidence base for international diabetes guidelines and novel drug indications that have improved the lives of people living with diabetes or prediabetes.
His research has been published in over 600 papers and his h index is 100. His work has been recognized by many awards, including the 2012 Canadian Diabetes Association’s Lifetime Achievement Award and the 2022 American Diabetes Association’s Outstanding Achievement in Clinical Diabetes Research Award.
Tara McCready
Program Director
Tara McCready
Program Director
Tara McCready, PhD, oversees a variety of collaborative programs at PHRI, and serves as Project Manager for PHRI research studies and registries.
She was recruited to PHRI as a Program Director for the Canadian Network and Centre for Trials Internationally (CANNeCTIN), a national network funded by the CIHR/CFI Clinical Research Initiative program to improve the prevention and treatment of cardiac and vascular diseases and diabetes.
Previously the Executive Director of the Canadian Maternal, Infant, Child and Youth Research Network, Tara holds a PhD in Biochemistry and a MBA in Technology Commercialization from the University of Alberta.
Stephanie Hall
Project Manager
Stephanie Hall
Project Manager
Stephanie Hall has more than 25 years of experience working in research for McMaster University. With PHRI since 2006, she has managed multiple large international trials. In her current role, she coordinates various studies in diabetes care. Stephanie has a business degree, and a degree in Health Care Administration.
Eli Lilly
VIDEO: Hertzel Gerstein discusses the key takeaways from the REWIND trial.
