Study Name: A Trial Comparing Cardiovascular Safety of Insulin Degludec Versus Insulin Glargine in Subjects With Type 2 Diabetes at High Risk of Cardiovascular Event (DEVOTE)
Principal Investigator: Margaret Lo, M.D.
Coordinator: Sarah Long, R.N.
What is the DEVOTE Study?
The primary objective of this study is to compare the cardiovascular safety of insulin degludec versus insulin glargine in subjects diagnosed with type 2 diabetes at high risk of cardiovascular events.
Who can participate?
Participants must be 50 years or older and have established Type 2 diabetes and heart disease – or risk factors for heart disease or chronic kidney disease. You must also be able to come for regular site visits and have telephone contact in between visits.
What do I have to do as a participant?
Eligible participants will visit Shands Medical Plaza in Gainesville, FL a total of 27 times. Following the screening and randomization visits, there will be 6 follow-up visits occurring every month and then every third month. You will be contacted by phone throughout the trial for a total of 35 times. Your participation will be approximately 3.5 – 5 years depending on when you enter the study. All subjects will continue their current antidiabetic therapy except for the basal insulin component (if any) that will be replaced by the investigational product. Participants will receive comprehensive diabetes care, such as regular health checks and medical testing and will also get free trial medication and blood sugar testing equipment, as well as compensation for travel time.