UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
Washington, D.C. 20549
------------
FORM 6-K
------------
REPORT OF FOREIGN ISSUER
Pursuant to Rule 13a-16 or 15d-16
of the Securities Exchange Act of 1934
December 12, 2007
------------
NOVO NORDISK A/S
(Exact name of Registrant as specified in its charter)
NOVO ALLE
DK-2880, BAGSVAERD
DENMARK
(Address of principal executive offices)
------------
Indicate by check mark whether the registrant files or will file annual reports
under cover of Form 20-F or Form 40-F
Form 20-F [X] Form 40-F [ ]
Indicate by check mark whether the registrant by furnishing the information
contained in this Form is also thereby furnishing the information to the
Commission pursuant to Rule 12g3-2(b) under the Securities Exchange Act of 1934.
Yes [ ] No [X]
If "Yes" is marked, indicate below the file number assigned to the registrant in
connection with Rule 12g-32(b):82-_____________________
RESEARCH UPDATE
FINAL PHASE 3 STUDY CONFIRMS VERY FAVOURABLE EFFECT OF LIRAGLUTIDE ON BLOOD
GLUCOSE CONTROL AND BODY WEIGHT
Novo Nordisk today announced clinical results from a one-year monotherapy study,
the last of five phase 3 studies needed for regulatory filing, investigating
liraglutide - the once-daily human GLP-1 analogue for treatment of type 2
diabetes.
The study, which is part of Novo Nordisk's LEAD(R) programme (Liraglutide Effect
and Action in Diabetes), included 746 patients with type 2 diabetes. Patients in
the study were randomised to treatment with one of two doses of liraglutide or 8
mg (maximal dose) of glimepiride, a widely used oral antidiabetic medication.
Approximately two thirds of the patients had previously been treated with one
oral antidiabetic medication, while one third had only been treated with diet
and exercise. This means that in this study liraglutide or glimepiride was given
to some patients instead of the oral antidiabetic medication they had been
taking previously, while others received liraglutide as their first diabetes
medication. The average HbA1c level at the beginning of the study was around
8.2% and the average body weight was 90 to 95 kg.
At both doses tested, liraglutide provided statistically significantly better
glucose control than glimepiride. On average, the patients treated with
liraglutide experienced a lowering of HbA1c of more than 1 percentage point,
while those patients who had previously only been treated with diet and exercise
saw HbA1c drop by more than 1.5 percentage points. The American Diabetes
Association treatment goal of HbA1c < 7% was reached by more than 50% of the
patients receiving the highest dose of liraglutide, while more than 60% of the
patients previously treated with diet and exercise reached the target.
As has been seen in previous studies where liraglutide has been given as
monotherapy, patients receiving liraglutide in this study experienced a very low
level of hypoglycaemia, contrasting with the glimepiride-treated group where
hypoglycaemia occurred in a larger number of patients. Furthermore, a
significant improvement in systolic blood pressure and a reduction of body
weight of between 3 and 4 kg were seen in patients treated with liraglutide when
compared to patients treated with glimepiride.
Liraglutide in monotherapy was well tolerated. The most frequently reported
adverse event during liraglutide treatment was transient, mild to moderate
nausea at a cumulated absolute level of below 30% over the full year of
treatment. After the first three months, the percentage of patients experiencing
nausea was in the low single digit range.
Mads Krogsgaard Thomsen, executive vice president and chief science officer of
Novo Nordisk, said: "We are very pleased with the clinical results in this phase
3 study. They show that the benefits of liraglutide are sustainable after one
year's treatment. All together, the phase 3 studies have compared liraglutide
with three widely used classes of anti-diabetic drugs - sulfonylurea, glitazone
and basal insulin - and have confirmed a statistically significant benefit of
liraglutide on the primary endpoint, HbA1c, as well as on body weight."
Novo Nordisk now expects to file for regulatory approval of liraglutide during
the second quarter of 2008.
Detailed results from the full LEAD(R) 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 impact Novo Nordisk's expectations for
the company's financial results for 2007, which were provided on 31 October in
connection with the release of the financial results for the first nine months
of 2007.
CONFERENCE CALL
At 5.00 pm CET today, corresponding to 11.00 am EDT, a conference call for
investors will be held. Investors will be able to listen in via a link on
novonordisk.com, which can be found under 'Investors - Download centre'.
ABOUT LIRAGLUTIDE, LEAD(R) 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 and by inhibiting appetite. In contrast to most other
antidiabetic treatments, liraglutide also leads to weight loss instead of weight
increase.
The LEAD(R) programme (Liraglutide Effect and Action in Diabetes) includes
around 4,000 patients with type 2 diabetes whose blood glucose is inadequately
controlled. The programme is comprised of five randomised, controlled,
double-blind studies conducted in more than 40 countries:
o The study reported on in this Stock Exchange Announcement is the LEAD 3
study.
o Results from the LEAD(R) 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).
o Results from the LEAD(R) 1 and LEAD(R) 2 studies were announced on 20
August 2007. The two studies investigated the effect of different doses of
liraglutide in combination with a single oral antidiabetic drug,
glimepiride and metformin respectively.
o Results from the LEAD(R) 4 study were announced on 14 September 2007. The
study investigated the effect of different doses of liraglutide in
combination with metformin and rosiglitazone.
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. The
company has the broadest diabetes product portfolio in the industry, including
the most advanced products within the area of insulin delivery systems. 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 25,800 employees in
79 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:
Media: Investors:
Outside North America: Outside North America:
Mike Rulis Mads Veggerby Lausten
Tel (direct): (+45) 4442 3573 Tel (direct): (+45) 4443 7919
mike@novonordisk.com mlau@novonordisk.com
Hans Rommer
Tel (direct): (+45) 4442 4765
hrmm@novonordisk.com
In North America: In North America:
Sean Clements Christian Qvist Frandsen
Tel (direct): (+1) 609 514 8316 Tel (direct): (+1) 609 919 7937
secl@novonordisk.com cqfr@novonordisk.com
Stock Exchange Announcement no 35 / 2007
SIGNATURES
Pursuant to the requirements of the Securities Exchange Act of 1934, the
Registrant has duly caused this report to be signed on its behalf of the
undersigned, thereunto duly authorized.
Date: December 12, 2007 NOVO NORDISK A/S
---------------------------------------------------
Lars Rebien Sorensen,
President and Chief Executive Officer