Interventional - Drug
The objective of the REMIT-iGarLixi study is to determine if, in patients with recently diagnosed T2DM, a 12-week course of iGlarLixi (combined basal insulin glargine and lixisenatide), metformin, and lifestyle approaches will achieve drug-free diabetes remission in a higher proportion of patients than standard diabetes therapy at 24 weeks (three months after the drugs are stopped).
Participants will be randomized to two treatment groups:
The primary outcome in this trial will be diabetes remission evaluated at 24 weeks after randomization.
Interventional - Drug
A multicentre, open-label, randomized controlled trial
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).
Natalia McInnes is the Joint Principal Investigator for the Diabetes Remission program at PHRI, and Assistant Professor in the Division of Endocrinology, McMaster University. She has received peer-reviewed research funding from CIHR and Canadian Diabetes Association and is supported by the Medicine Internal Career Award from McMaster University. Her research interests include remission of pre-diabetes and type 2 diabetes, and the relationship between dysglycemia and ectopic fat deposition.
She received her medical degree from the University of British Columbia. After completing her Internal Medicine and Endocrinology training, she pursued MSc in Health Research Methodology at McMaster University.
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.
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