Interventional - Drug
(The pilot was not powered to provide conclusive results on effects of insulin on clinical events. If safe and associated with glucose lowering a full scale trial was planned.)
The 24-hour difference in mean glucose between the two study groups.
Secondary endpoints: The difference in mean glucose level achieved at 7 days or hospital discharge (whichever is first); Tthe difference in mean glucose level achieved at 30 days between study groups; nonfatal recurrent myocardial infarction; nonfatal stroke; cardiovascular death (as a composite and as separate outcomes); rehospitalization for congestive heart failure; all-cause mortality; resuscitated cardiac arrest or life-threatening arrhythmia (as a composite and as separate outcomes); cardiogenic shock; cardiac procedures; rehospitalization for any cause; symptomatic and severe hypoglycemic episodes; hypokalemic episodes.
All clinical event endpoints were adjudicated.
Interventional - Drug
Randomized, open label, placebo control, parallel group
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).
Jackie Bosch started working with Salim Yusuf in 1993, before PHRI was formally created, as she was completing her Masters in Clinical Epidemiology, with the intent to learn how to do clinical trials so she could run trials in post-stroke rehabilitation. Most recently, she has been a co-investigator on large trials in primary and secondary prevention of cardiovascular disease and diabetes, as well as understanding the causes of functional decline as well as developing simple, internationally applicable interventions to improve post-stroke disability.
She is Assistant Dean of the Occupational Therapy program, School of Rehabilitation Sciences, McMaster University, and has received awards such as the (McMaster) President’s Award for Outstanding Service, and the PHRI Award for Outstanding Contributions to Global Collaborations. She has more than 65 peer-reviewed publications.
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