Interventional - Drug
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.
Time to first occurrence (after randomization) of the composite endpoint of death from CV causes, nonfatal MI, or nonfatal stroke.
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 Slides
Interventional - Drug
Phase 3, randomized, double-blind, placebo-controlled, parallel
Deputy Director; Senior Scientist
Hertzel Gerstein is Deputy Director, PHRI, and our Senior Scientific Program Lead, Diabetes, as well as a Professor, Medicine, McMaster University. He is also Director of the Division of Endocrinology & Metabolism and Director of the Diabetes Care and Research Program. He has pioneered the application of large simple outcome trials to people with diabetes globally, and developed the concept of dysglycemia as an important risk factor for many of the serious health outcomes that afflict people with an elevated glucose level regardless of diabetes status. He currently leads clinical trials and epidemiological studies related to: a) the prevention and therapy of diabetes and its many consequences, and b) the role of dysglycemia and relative insulin insufficiency on the development of diabetes, cardiovascular disease, cognitive impairment and other chronic conditions. Key studies in which he has played or continues to play a major leadership role include HOPE, MICRO HOPE, ACCORD, DREAM, EpiDREAM, ORIGIN, TIDE, ACE, ELIXA and REWIND.
Hertzel Gerstein has published more than 300 papers, editorials and commentaries, mainly on diabetes-related issues and co-edited the textbook Evidence-Based Diabetes Care. He is an Associate Editor for ACP Journal Club, and is on the editorial board of the Journal of Diabetes and Lancet Diabetes and Endocrinology. He has received several honors including the Canadian Diabetes Association’s Young Scientist Award (1999), Frederick G. Banting award (1999), Charles H. Best award (2007) and Lifetime Achievement Award (2012).
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.
Senior Research Coordinator
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.
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