Interventional - Drug
The objective of AMPLITUDE-O was to:
i Demonstrate that efpeglenatide (4 or 6 mg weekly) is noninferior to placebo on 3-point major adverse cardiac event (MACE) in high-risk people with Type 2 diabetes mellitus (T2DM) and cardiovascular and/or renal disease.
ii Demonstrate that efpeglenatide (4 or 6 mg weekly) is superior to placebo in people with T2DM on the following parameters: 3-point MACE; MACE, revascularization or unstable angina,; a renal composite outcome; and other cardiovascular outcomes.
Dr. Gerstein, global study chair of AMPLITUDE-O, was assisted by PHRI statisticians Leanne Dyal, Laura Heenan, Chinthanie Ramasundarahettige, Olga Shestakovska, and Purnima Rao-Melacini.
Interventional - Drug
Double-blind, Placebo-controlled, Parallel-group RCT
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).
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