In Three Studies Once-Daily Liraglutide Reduced Blood Sugar, Weight, and Blood Pressure in Patients with Type 2 Diabetes

June 9, 2008

San Francisco, CA, USA – Data presented at the 68th Scientific Sessions of the American Diabetes Association (ADA) demonstrated that liraglutide, a once-daily analog of human Glucagon-Like Peptide-1 (GLP-1) led to statistically significant improvements in blood sugar (glucose control), body weight, and systolic blood pressure in patients with 2 diabetes.

Results indicated that liraglutide, in combination with oral antidiabetic drugs (OADs), statistically significantly reduced HbA1c and body weight. In addition, the reduction seen in fasting blood glucose was significant. Liraglutide may further improve the cardiovascular risk profile of patients with type 2 diabetes by also reducing systolic blood pressure.

“Many people with diabetes are in a constant struggle to not only control their blood sugar but also to lose weight and lower their blood pressure,” said Professor Stephen Colagiuri, Professor of Metabolic Health, University of Sydney, Australia. “Once-daily liraglutide may represent a considerable advance in the treatment of type 2 diabetes.”

The data presented are from the LEAD™ 1, 2 and 5 studies, three of the five studies which make up the Phase 3 program for liraglutide. Unlike some other drug development programs, each of these studies compared liraglutide to an active comparator typically used in the treatment of type 2 diabetes. The following table highlights key outcomes from the studies within the liraglutide 1.8 mg group vs active comparator:

* Although systolic blood pressure was reduced in the liraglutide group, it did not reach statistical significance.
† Statistically significant

Key:
lira Liraglutide
glim Glimepiride
rsg Rosiglitazone
glar Insulin glargine
met Metformin

Treatment with liraglutide + metformin + glimepiride resulted in the greatest decrease in HbA1c (-1.3%) compared with other regimens. This statistically significant reduction was also greater than observed with insulin glargine + metformin + glimepiride. In addition, liraglutide reduced systolic blood pressure in all trials with a statistically significant difference in two of the three trials (from -2.7 to -4.5 mmHg) versus comparator treatments. Patients in the liraglutide arm of each study had statistically significant weight loss versus comparator treatments. As an add-on to metformin + glimepiride, liraglutide demonstrated strong efficacy versus insulin glargine, showing significant difference in change in body weight of 3.4 kg.

Safety and Tolerability of Liraglutide

The most common adverse events in all three trials were gastrointestinal in nature (i.e. nausea, diarrhea and vomiting), and were mostly mild and transient. Minor hypoglycemia was reported in 4 to 27 percent of patients taking liraglutide in these trials.

The Importance of type 2 diabetes Risk Factors

Addressing risk factors for cardiovascular disease, including HbA1c, body weight, and blood pressure, is key to managing type 2 diabetes.

Key facts:

  • 43 percent of patients with type 2 diabetes are not achieving their target blood sugar levels.
  • Weight gain is one of the biggest challenges for patients with type 2 diabetes; up to 90 percent of patients with type 2 diabetes are overweight.
  • Approximately three out of every four patients with type 2 diabetes have high blood pressure.

About the Study Design

The three 26-week randomized, controlled, double-blind clinical studies, which are part of Novo Nordisk’s LEAD™ clinical program (Liraglutide Effect and Action in Diabetes) , involved more than 2,700 patients with type 2 diabetes. Patients in the studies were randomized to treatment with liraglutide, placebo, or an active comparator, in combination with either glimepiride, metformin, or both glimepiride and metformin.

About Liraglutide

Liraglutide is a once-daily analog of the naturally occurring hormone human Glucagon-Like Peptide-1 (GLP-1). Liraglutide works by stimulating the release of insulin only when glucose levels become too high and by inhibiting appetite. On 23 May 2008, Novo Nordisk submitted a New Drug Application to the Food and Drug Administration (FDA) in the US as well as a marketing authorisation application to the European Medicines Agency (EMEA) in Europe, for the approval of liraglutide for the treatment of patients with type 2 diabetes.

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 hemostasis 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 26,300 employees in 80 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’.

Further information:

Media: An Phan, 609-558-0420

Investors: Christian Qvist Frandsen, 609-919-7937