UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
Washington, D.C. 20549
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FORM 6-K
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REPORT OF FOREIGN ISSUER
Pursuant to Rule 13a-16 or 15d-16
of the Securities Exchange Act of 1934
JUNE 21 2007
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NOVO NORDISK A/S
(Exact name of Registrant as specified in its charter)
NOVO ALLE
DK-2880, BAGSVAERD
DENMARK
(Address of principal executive offices)
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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
LIRAGLUTIDE PROVIDES SIGNIFICANTLY BETTER GLUCOSE CONTROL THAN INSULIN GLARGINE
IN PHASE 3 STUDY
Novo Nordisk today announced clinical results from the first of five phase 3
studies with liraglutide - the once-daily human GLP-1 analogue. The 26-week
study is part of the LEAD(TM) (Liraglutide Effect and Action in Diabetes)
programme and included 581 patients with type 2 diabetes inadequately controlled
by two of the most widely used oral antidiabetic drugs: metformin and a
sulfonylurea (glimepiride). All patients in the study continued the two oral
drugs and were randomised to add one daily injection of liraglutide, placebo or
insulin glargine.
The average HbA1c level at the beginning of the study was between 8.0% and 8.5%
and at the end of the study, more than 50% of patients in the liraglutide 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 group
was more than 0.2 percentage points better than in the insulin glargine group, a
difference which is statistically significant.
The average weight of the patients at the beginning of the study was
approximately 85 kg. At the end of the study, the difference in body weight
between the liraglutide and insulin glargine treatment groups was on average 3.5
kg, statistically significant in favour of liraglutide.
Liraglutide in combination with metformin and glimepiride was well tolerated.
The most frequently reported adverse event in the liraglutide arm was nausea at
an absolute level of between 10 and 15%. As expected, the combination of a GLP-1
analogue with a sulfonylurea leads to some of the patients experiencing
hypoglycaemia. The overall hypoglycaemia event rate in the liraglutide and
insulin glargine groups was not significantly different.
Mads Krogsgaard Thomsen, executive vice president and chief science officer of
Novo Nordisk, said: "We are very pleased with these first results from the
liraglutide phase 3 programme, showing that liraglutide provides improved
glucose control compared to insulin glargine while, at the same time, leading to
significant weight loss."
Novo Nordisk expects to announce headline results from the remaining four
LEAD(TM) studies during the second half of 2007 and the first quarter of 2008.
Detailed results from the full LEAD(TM) 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 2 May in
connection with the release of the financial results for the first three months
of 2007.
CONFERENCE CALL
At 12.30 pm CET today, corresponding to 6.30 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(TM) 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(TM) 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.
HbA1c is an abbreviation for glycated haemoglobin HbA1c. The level of HbA1c
reflects the average blood glucose level over the past 2-3 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 more than 23,600 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:
Elin K Hansen Mads Veggerby Lausten
Tel (direct): (+45) 4442 3450 Tel (direct): (+45) 4443 7919
ekh@novonordisk.com mlau@novonordisk.com
Katrine Sperling Hans Rommer
Tel (mobile): (+45) 3079 6718 Tel (direct): (+45) 4442 4765
krsp@novonordisk.com hrmm@novonordisk.com
In North America: In North America:
Sean Clements Christian Qvist Frandsen
Tel (direct): (+1) 609 902 9164 Tel (direct): (+1) 609 919 7937
secl@novonordisk.com cqfr@novonordisk.com
Stock Exchange Announcement no 17 / 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: June 21 2007 NOVO NORDISK A/S
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Lars Rebien Sorensen,
President and Chief Executive Officer