Novo Nordisk, international scientific community to conduct outcomes trial for liraglutide

Novo Nordisk announced details of the company’s cardiovascular outcomes trial for liraglutide (rDNA origin) injection (Victoza), which is set to start this autumn.
The trial, called 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 glucagon-like peptide (GLP)-1 analog liraglutide. The trial satisfies the new FDA guideline for type 2 diabetes treatments.

LEADER is a long-term, multicenter, international, randomized, double-blind, placebo-controlled, phase 3b trial that will aim to enroll about 9,000 patients who will be treated for up to 5 years. The trial will compare liraglutide plus standard of care with standard of care alone in people with type 2 diabetes.

The trial’s protocol has been designed in close collaboration with an international-expert steering committee, as well as U.S. and European Union regulatory authorities, and with assistance from the Population Health Research Institute at McMasters University in Hamilton, Ontario. Furthermore, an independent data monitoring committee will monitor progress of the trial and ensure that it meets the highest standards of ethics and subject safety, according to Princeton, N.J.-based Novo Nordisk.

“There is a well-established association between cardiovascular disease (CVD) and type 2 diabetes,” said John Buse, MD, 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. 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 an increase in CVD risk. As such, FDA often requires additional studies to determine that type 2 diabetes drugs do not further increase CVD risk.