In part 3 of this Exclusive Interview, Dr. Samuel Engel talks with Diabetes in Control Publisher Steve Freed during the ADA meeting in San Diego, California about the cardiovascular study portion of the ertugliflozin trial.
Dr. Sam Engel is the Associate Vice President, Cardiometabolic and Women’s Health at Merck Research Laboratories.
Transcript of this video segment:
Steve Freed: I presume that in order to get approval you have to do a cardiovascular study. Where are you along those lines?
Samuel Engel: So our cardiovascular outcome study is ongoing, it’s fully enrolled. Last year we had announced that we were doubling the size of the study and so we have completed enrollment of approximately 8,000 subjects in that study. Obviously the study remains blinded but we are looking forward to those results. Currently, it’s projected that the study should end sometime around 4th quarter of 2019. Now it is an event-driven study, so if the event rates are higher or lower than we anticipate, then the study completion date could be affected as well.