Novo Nordisk partners with international scientific community for Victoza® cardiovascular outcomes trial

Novo NordiskNovo Nordisk announced 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 Victoza® and potentially show the ability of Victoza® to improve cardiovascular outcomes. The trial also satisfies the new FDA guideline for type 2 diabetes treatments.

Because of the scientific opportunity this trial presents, the 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 McMaster 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.

"There is a well-established association between cardiovascular disease (CVD) and type 2 diabetes," said Dr John Buse, Chief of Endocrinology and Director of the Diabetes Care Centre 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 more than 50% of all diabetes fatalities. As a result there is a serious unmet need for further long-term studies to help reduce 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,(1) hypertension1 and dyslipidaemia.(2) The high prevalence of co-morbidities in combination with hyperglycaemia are the likely contributors to the increased risk of cardiovascular disease complications in adults with type 2 diabetes.(3) Yet, only 10% of diabetes patients have good control of both blood glucose, hypertension and dyslipidaemia.(4)

In addition to the underlying link between CVD and type 2 diabetes, some older type 2 diabetes treatments may be associated with increases in CVD risk.(5) Evidence of this association prompted regulatory authorities to require additional studies of type 2 diabetes treatments in order to ascertain that all newer drugs do not unacceptably increase CVD risk.(5)

Previous data from the LEAD™ (Liraglutide Effect and Action in Diabetes) trials has shown Victoza® not only to improve glucose control (HbA1c -1.0–1.6%)(6,7,8,9,10,11) but also to induce weight loss of 2–3 kg on average (6,7,8,9,10) lower blood pressure by 2–6 mmHg (6,7,8,9,10,11) and potentially reduce lipids and other cardiovascular risk markers such as total cholesterol, LDL, TG, FFA, BNP, CRP(12) in patients with type 2 diabetes.

LEADER™ (Liraglutide Effect and Action in Diabetes: Evaluation of Cardiovascular Outcome Results) is a long-term, multicentre, international, randomised, double-blind, placebo-controlled, phase 3b trial which will include around 9,000 patients over a five-year period.

The trial will compare liraglutide added to standard of care with standard of care alone in people with type 2 diabetes.

GLP-1 analogue Victoza® (liraglutide)
Once-daily Victoza® is the first human GLP-1 (Glucagon-Like Peptide-1) analogue developed for the treatment of type 2 diabetes. Victoza® lowers blood glucose by stimulating the release of insulin and lowering of glucagon secretion when blood sugar levels are high and also by slowing gastric emptying.(13) Victoza® also reduces body weight and body fat mass through mechanisms involving reduced hunger and lowered energy intake.(14)

Victoza® is a once-daily injection taken any time of day independent of meals.(14)

Novo Nordisk received marketing authorisation for Victoza® on 30 June 2009 in the EU, 20 January 2010 in Japan and 25 January 2010 in the US. It has been launched in the US, UK, Germany and several other European markets.

About Novo Nordisk
Headquartered in Denmark, Novo Nordisk is a global healthcare company with 87 years of innovation and leadership in diabetes care. The company also has leading positions within haemophilia care, growth hormone therapy and hormone replacement therapy. For more information, visit

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14. Victoza® Summary of Product Characteristics (SPC) is available at Victoza has market authorisation in the EU and US.