Interventional - Drug
REMIT-iDegLira is a multicentre, open-label, randomized controlled trial in patients with recently-diagnosed type 2 diabetes (T2DM).
Participants will be randomized to two treatment groups:
(a) A 16-week period of lifestyle coaching support, metformin and a once-daily injection of IDegLira, and;
(b) Standard diabetes therapy, and followed for a total of 68 weeks (1 year and 4 months).
In all participants with HbA1C less than 7.3% at the 16-week visit, glucose-lowering medications will be discontinued and participants will be encouraged to continue with lifestyle modifications and regular glucose monitoring.
Participants with HbA1C greater than or equal to 7.3% at this visit, or whose HbA1C is greater than or equal to 7.0% at or after the 28 week visit, will receive standard glycemic management.
Drug-free diabetes remission defined as a HbA1C less than 6.5% without use of glucose-lowering agents for at least 12 weeks.
Interventional - Drug
Multicentre, open-label RCT
2019 - 2023
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).
Zubin Punthakee is an Associate Professor in the Departments of Medicine (endocrinology and metabolism) and Pediatrics, at McMaster University. His research interests are: clinical trials of diabetes management; association between obesity and insulin resistance/diabetes, especially in youth; health care delivery and outcomes during transition from pediatric to adult care; and long-term outcomes of pediatric endocrine diseases.
At PHRI, he has held leadership roles in the TIDE trial, ORIGINALE study and RICH LEGACY study. He has published more than 22 articles, been supported by Research Career Awards from Hamilton Health Sciences and the Department of Medicine at McMaster University, and holds research grants from agencies including the Canadian Institutes of Health Research.
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 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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