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 novonordisk.com. 1. Agency for Healthcare Research and Quality. Prevalence of obesity and other chronic health conditions among diabetic adults in the US community population, 2001. Medical Expenditure Panel Survey. 2004. Available at URL: http://www.meps.ahrq.gov/mepsweb/data_files/publications/st34/stat34.pdf. Last accessed March 2010.
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5. Food and Drug Administration. Guidance for Industry: Diabetes Mellitus — Evaluating cardiovascular risk in new antidiabetic therapies to treat type 2 diabetes. US Department of Health and Human Services. December 2008.
6. Marre M et al. Liraglutide, a once-daily human GLP-1 analogue, added to a sulphonylurea over 26 weeks produces greater improvements in glycaemic and weight control compared with adding rosiglitazone or placebo in subjects with Type 2 diabetes (LEAD-1 SU). Diabetic Medicine. 2009;26: 268–278.
7. Nauck M et al. Efficacy and safety comparison of liraglutide, glimepiride, and placebo, all in combination with metformin, in type 2 diabetes. The LEAD (Liraglutide Effect and Action in Diabetes)-2 study. Diabetes Care. 2009;32:84–90.
8. Garber A et al. Liraglutide versus glimepiride monotherapy for type 2 diabetes (LEAD-3 Mono): a randomised, 52-week, phase III, double-blind, parallel-treatment trial. Lancet. 2009; 373(9662):473-481.
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10. Russell-Jones D et al. Liraglutide vs insulin glargine and placebo in combination with metformin and sulphonylurea therapy in type 2 diabetes mellitus: a randomised controlled trial (LEAD-5 met+SU). Diabetologia. 2009;52(10):2046-55.
11. Buse J, et al. Liraglutide once a day versus exenatide twice a day for type 2 diabetes: a 26-week randomised, parallel-group, multinational, open-label trial (LEAD-6). Lancet. 2009;374(9683):39-47.
12. Plutzky J, Garber A, Toft A et al. Meta analysis demonstrates that liraglutide, a once-daily human GLP-1 analogue, significantly reduces lipids and other markers of cardiovascular risk in type 2 diabetes. Diabetologia. 2009; in press.
13. Knudsen et al. Potent derivatives of glucagon-like peptide-1 with pharmacokinetic properties suitable for once daily administration. J Med Chem 2000;43:1664–9.
14. Victoza® Summary of Product Characteristics (SPC) is available at www.ema.europa.eu. Victoza has market authorisation in the EU and US.