The trial named LEADER™ (Liraglutide Effect and Action in Diabetes: Evaluation of Cardiovascular Outcome Results) aims to assess and confirm the cardiovascular safety of the company’s new once-daily human GLP-1 analog Victoza®. The trial satisfies the new FDA guideline for type 2 diabetes treatments.
The protocol of this trial has been designed in close collaboration with an international expert Steering Committee, as well as U.S. and EU regulatory authorities, and with assistance from the Population Health Research Institute (PHRI) at McMasters University, Canada. Furthermore, an independent Data Monitoring Committee (DMC) will monitor progress of the trial and ensure that it meets the highest standards of ethics and subject safety.
“There is a well-established association between cardiovascular disease (CVD) and type 2 diabetes,” says Dr. John Buse, Chief of Endocrinology and Director of the Diabetes Care Center at the University of North Carolina School of Medicine, and Chairman of the LEADER™ Steering Committee. “In fact, CVD ranks as the major cause of death in diabetes, accounting for 50% of all diabetes fatalities. As a result there is a serious unmet need for further long-term studies to help assess the risk of CVD in patients with type 2 diabetes.”
The vast majority of people with type 2 diabetes suffer from a range of co-morbidities such as obesity, hypertension, and dyslipidemia. The high prevalence of co-morbidities in combination with hyperglycemia are likely contributors to the increased risk of CVD complications in adults with type 2 diabetes. Yet only 10% of diabetes patients have good control of blood sugar, hypertension and dyslipidemia.
In addition to the underlying link between CVD and type 2 diabetes, some diabetes treatments may be associated with increase in CVD risk. As such, the FDA often requires additional studies to determine that type 2 diabetes drugs do not further increase CVD risk.