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Novo Nordisk announced today details of the company’s cardiovascular outcomes trial for Victoza® (liraglutide) which is set to start in the autumn of 2010.
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 analogue liraglutide and subsequently test the ability of liraglutide to improve cardiovascular outcomes. The trial also satisfies the new US FDA guideline for type 2 diabetes treatments.
The LEADERTM trial protocol has been designed in close collaboration with an international expert Steering Committee as well as US 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 patient safety.
“Cardiovascular disease (CVD) is a common and serious co-morbidity in people with type 2 diabetes, which accounts for over 50% of diabetes fatalities,” said Professor Stephen Bain, Chair in Medicine (Diabetes) at Swansea University, and Diabetes Lead Clinician for the ABM University Health Board. “Long-term studies, considering cardiovascular outcomes as well as glycaemic control, in type 2 diabetes patients are therefore essential and an important element of diabetes research and development.”
The vast majority of people with type 2 diabetes suffer from a range of co-morbidities, such as obesity,2 hypertension,2 and dyslipidaemia. Control of glucose levels, blood pressure and cholesterol levels can dramatically delay or prevent the microvascular and macrovascuar complications of diabetes. Yet, only 10% of diabetes patients have good control of both blood glucose, hypertension and dyslipidaemia.
The FDA recommends studies of type 2 diabetes treatments in order to ascertain that all newer drugs do not unacceptably increase CVD risk.
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