Study Type
Interventional - Drug
completed
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.
Download AMPLITUDE O slides from ADA 2021Study Design
Double-blind, Placebo-controlled, Parallel-group RCT
NO. of Countries
28
NO. of Sites
344
NO. of Participants
4076
Study Period
2018-2020
Sponsor
Sanofi
Hertzel Gerstein
Interim Executive Director; Senior Scientist
Hertzel Gerstein
Interim Executive Director; Senior Scientist
Hertzel Gerstein is PHRI’s Interim Executive Director and Senior Lead of the Diabetes Scientific Program. He is also a Professor of Medicine at McMaster University where he holds the Population Health Research Institute Chair in Diabetes; an Endocrinologist; Director of the Boris Clinic Diabetes Care and Research Program; Chair of Diabetes Clinical Trials Network Canada; and a Fellow of both the Canadian Academy of Health Sciences and the Royal Society of Canada.
Gerstein pioneered and firmly established international long-term diabetes-focused outcomes trials as the norm to support Evidence-Based Diabetes Care. Randomized trials that he designed and led have collectively included more than 90,000 people with either diabetes or prediabetes to date, and have studied and identified clinically important, life-saving diabetes therapies. These trials were supported by the US National Institute of Health, the Canadian Institutes of Health Research, other Canadian peer-review agencies, and by industry. Together, they have substantially expanded the evidence-base pertaining to the prevention, remission, and treatment of diabetes and its consequences, and some of their findings have provided the evidence base for international diabetes guidelines and novel drug indications that have improved the lives of people living with diabetes or prediabetes.
His research has been published in over 600 papers and his h index is 100. His work has been recognized by many awards, including the 2012 Canadian Diabetes Association’s Lifetime Achievement Award and the 2022 American Diabetes Association’s Outstanding Achievement in Clinical Diabetes Research Award.
