Research Update

* Reuters is not responsible for the content in this press release.

Fri Jun 6, 2008 12:26pm EDT

  BAGSVAERD, DENMARK, Jun 06 (MARKET WIRE) -- 
 Novo Nordisk today announced headline clinical results from a phase 3
clinical study (LEAD(TM) 6) comparing the effects of liraglutide, a
once-daily human GLP-1 analogue, with exenatide, a twice-daily GLP-1 analogue.
The 26-week study, which is the first study to provide a direct comparison
between the two GLP-1 analogues, included 464 people with type 2 diabetes who
were randomised to treatment with either liraglutide once daily or exenatide
twice daily, as add-on to their existing treatment consisting of metformin,
sulfonylurea, or a combination of both.

    The average HbA1c level at the beginning of the study was slightly above 8%
and
the primary endpoint was the change in HbA1c. Patients treated with liraglutide
achieved a reduction in HbA1c of more than 1.1 percentage points, compared to
a reduction in HbA1c of less than 0.8 percentage points in the exenatide
group, a difference which was statistically significant. Liraglutide
treatment led to statistically significantly more patients achieving both the
American
DiabetesAssociation (ADA) and American Association of Clinical Endocrinologists
(AACE)
HbA1c targets of < 7% and < = 6.5%, respectively. Specifically, close to 55% of
patients in the liraglutide group reached the ADA target, compared to close
to 45% in the exenatide group. Likewise, around 35% of patients treated with
liraglutide achieved the AACE target, compared to around 20% for patients
treated with exenatide.

    The patients' average weight at the beginning of the study was between 90
and
95 kg. Both patients treated with liraglutide and patients treated with
exenatide lost on average around 3 kg during the course of the study, with a
trend towards more weight loss in the liraglutide group. Among patients
previously treated with metformin alone, this difference was 1 kg in favour of
liraglutide (not statistically significant).

    The most frequently reported adverse event for both liraglutide and
exenatide
was nausea at a level of around 25% (percent of all study participants
reporting nausea at least once). In the liraglutide group, the percentage of
patients
reporting nausea in each week fell to low single-digit numbers after 8-10
weeks, similar to the level observed in a background population. In the
exenatide group, the level after 8-10 weeks of treatment remained at the
level of 10%.

    As expected, the overall rate of hypoglycaemia in the study was low. The
rate
of minor hypoglycaemia was statistically significantly lower in the liraglutide
group, compared to the exenatide group.

    Mads Krogsgaard Thomsen, executive vice president and chief science officer
of
Novo Nordisk, said: "We are very encouraged by the fact that the study showed
that once-daily liraglutide leads to statistically significantly better
blood glucose control than twice-daily exenatide. In addition, liraglutide
treatment leads to weight loss and is associated with a very low risk of
hypoglycaemia."

    The results of the phase 3 trial do not impact Novo Nordisk's expectations
for the
company's financial results for 2008, which were provided on 30 April in
connection with the release of the financial results for the first quarter of
2008.

    About liraglutide and HbA1c

    Liraglutide is a once-daily  human GLP-1 analogue. 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   US  Food  and   Drug Administration as well  as a
marketing  authorisation application  to the European Medicines  Agency, for
the  approval of liraglutide  for the treatment of people with type 2
diabetes.

    HbA1c is an abbreviation for glycated haemoglobin HbA1c. The level of HbA1c
reflects the average blood glucose  level over the past two  to three months
 and a  decrease  is therefore  a measure  of  treatment effect. The  higher 
the
blood  glucose  the more  glucose  binds  to haemoglobin (glycation).

    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 homeostasis
management, growth hormone therapy and hormone replacement therapy. Novo Nordisk
manufactures and markets pharmaceutical products and services that make a
significantdifference 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'. For more information, visit
novonordisk.com

    Stock Exchange Announcement no 32 / 2008


 Copyright Copyright Hugin AS 2008.
All rights reserved.

    



Copyright 2008, Market Wire, All rights reserved.

-0-
Comments (0)
This discussion is now closed. We welcome comments on our articles for a limited period after their publication.