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Vienna, Austria - New data from the extension phase of the LEAD™ 6 phase 3b study presented today at the 45^th Annual Meeting of the European Association for the Study of Diabetes (EASD) shows that patients with type 2 diabetes further improved their treatment outcome by switching from two daily injections of Byetta^® (exenatide, 10 µg dose) to one daily injection of Victoza^® (liraglutide, 1.8 mg dose).

The 14-week extension study showed that patients switched to Victoza^® treatment from Byetta^® experienced a statistically significant improvement in blood sugar control (average reductions in HbA_1c and fasting plasma glucose of 0.3 percentage points and 0.9 mmol/l, respectively)[1].

“This information is very useful for physicians looking to improve patient outcomes in diabetes,” said Dr Wolfgang Schmidt, professor and chair of the Department of Medicine at St. Josef-Hospital and one of the principal investigators in the trial. “The data shows that switching patients from Byetta^® to Victoza^® results in better blood sugar control and lower hypoglycaemia risk for these patients. Furthermore, the switch can be done overnight whereby patients receive the last dose of Byetta^® in the evening followed by the first dose of Victoza^® the next morning.”

Other benefits associated with the switch to Victoza^® included additional reductions in weight (-0.9 kg) and systolic blood pressure (-3.8 mmHg).¹

Dr Wolfgang Schmidt further noted that the percentage of patients on Victoza^® who experienced nausea decreased throughout both the main and extension trials from around 12–17% during the first weeks of treatment[2] to less than 2% in the 14-week extension phase.¹

“Some people experience mild to moderate nausea when they start on GLP-1 treatment. This study confirms that nausea is transient with Victoza^® since patients experience less nausea with this treatment over time,” Dr Schmidt said.

About the LEAD™ 6 trial and extension phase

In the LEAD™ 6 extension trial, patients were either switched from Byetta^® to Victoza^® or continued on Victoza^® for a period of 14 weeks. All 389 patients who completed the randomised trial entered into the extension phase.¹

Results from the LEAD™ 6 (Liraglutide Effect and Action in Diabetes) trial have been published in The Lancet². LEAD™ 6 was a 26-week, randomised, open-label, direct comparison between Victoza^® and Byetta^®.

About Victoza®

Victoza^® is a human glucagon-like peptide-1 (GLP-1) analogue developed for the treatment of type 2 diabetes. Victoza^® lowers blood glucose by stimulating the release of insulin when blood sugar levels are high and also by slowing gastric emptying. Victoza^® also reduces body weight and body fat mass through mechanisms involving reduced hunger and lowered energy intake.

The European Commission granted marketing authorisation for Victoza® on 30 June 2009 for all 27 European Union member states and it is already on the market in Germany, the UK and Denmark. According to this authorisation, Victoza® is indicated for the treatment of adults with type 2 diabetes mellitus to achieve glycaemic control as a:

·       combination treatment with metformin or a sulphonylurea in patients with insufficient glycaemic control despite maximal tolerated dose of monotherapy with metformin or sulphonylurea, and

·       combination treatment with metformin and a sulphonylurea or metformin and a thiazolidinedione in patients with insufficient glycaemic control despite dual therapy.

For more information on Victoza^®, please visit novonordisk.com/Victoza-PressRoom

Novo Nordisk is a healthcare company and a world leader in diabetes care. In addition, Novo Nordisk has a leading position within areas such as haemostasis management, growth hormone therapy and hormone replacement therapy. Novo Nordisk manufactures and markets pharmaceutical products and services that make a significant difference to patients, the medical profession and society. With headquarters in Denmark, Novo Nordisk employs approximately 28,500 employees in 81 countries, and markets its products in 179 countries. Novo Nordisk’s B shares are listed on the stock exchanges in Copenhagen and London. Its ADRs are listed on the New York Stock Exchange under the symbol ‘NVO’. For more information, visit novonordisk.com.

Further information:

References

[1] Buse J et al. A switch from twice-daily exenatide to once-daily liraglutide further improves glycaemic control in patients with type 2 diabetes on oral patients. Diabetologia 2009; 52 (Suppl. 1): Abstract 2

[2] Buse J, Rosenstock J, Sesti G, Schmidt WE, Montanya E, Brett J, Zychma M, Blonde L for the LEAD 6 study group. 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.