Phase 3 study confirms that liraglutide treatment leads to…

Phase 3 study confirms that liraglutide treatment leads to both glucose and weight reduction with a low risk of hypoglycaemic events Novo Nordisk today announced clinical results from the fourth of five phase 3 studies with liraglutide

BAGSVAERD, Denmark | September 14, 2007 | Novo Nordisk today announced clinical results from the fourth of five phase 3 studies with liraglutide – the once-daily human GLP-1 analogue. The 26-week LEAD® 4 study is part of the LEAD® (Liraglutide Effect and Action in Diabetes) programme. The study investigated the effect of different doses of liraglutide in combination with metformin and rosiglitazone, and included 533 patients with type 2 diabetes.

After a run-in period of metformin and rosiglitazone, patients in the study were randomised to add-on treatment with either liraglutide or placebo. The average HbA1c level at the beginning of the study was around 8.5% and the average body weight was just above 95 kg.

At the end of the study, more than 50% of the patients in the liraglutide-treated group had reached the American Diabetes Association goal of HbA1c < 7%. Furthermore, more than 35% achieved the American Association of Clinical Endocrinologists HbA1c target of <= 6.5%. The HbA1c reduction achieved in the liraglutide-treated group was close to 1.5 percentage points compared to baseline. In addition, a weight difference of around 2.5 kg compared to placebo in favour of liraglutide was observed.

Liraglutide in combination with metformin and rosiglitazone was well tolerated. The most frequently reported adverse event during liraglutide treatment was nausea, reported by around 30-40% of the subjects with a frequency decreasing over time. As expected, a low rate of hypoglycaemic events was reported, and these were related to the degree of blood glucose control.

Mads Krogsgaard Thomsen, executive vice president and chief science officer of Novo Nordisk, said: "The new clinical results confirm the strong efficacy data in terms of glucose control with a low risk of hypoglycaemia together with weight loss that we have seen in the previously announced phase 3 trials. With data from now approximately 85% of all patients in the phase 3 programme, we are confident that liraglutide will become a valuable new treatment option for people with type 2 diabetes."

Novo Nordisk expects to announce headline results from the last outstanding study (LEAD® 3) before the end of the first quarter of 2008. Detailed results from the full LEAD® programme are expected to be published in peer-reviewed journals and communicated at future scientific meetings.

The results of the phase 3 trial do not change Novo Nordisk’s expectations for the company’s financial results for 2007, which were provided on 3 August in connection with the release of the financial results for the first six months of 2007.

About liraglutide, LEAD® and HbA1c

Liraglutide is a once-daily human analogue of the naturally occurring hormone Glucagon-Like Peptide-1 (GLP-1). The compound is being developed by Novo Nordisk for the treatment of type 2 diabetes, and is currently in phase 3 development. Liraglutide works by stimulating the release of insulin only when glucose levels become too high. In contrast to most other antidiabetic treatments, liraglutide also leads to weight loss instead of weight increase.

The LEAD® programme (Liraglutide Effect and Action in Diabetes) is comprised of five randomised, controlled, double-blind studies conducted in more than 40 countries. The programme includes around 3,800 patients with type 2 diabetes whose blood glucose is inadequately controlled.

Results from the LEAD® 5 study were reported on 21 June 2007. This study compared the effect of liraglutide with insulin glargine when used as add-on therapy in patients inadequately controlled by two of the most widely used oral antidiabetic drugs: metformin and a sulfonylurea (glimepiride)