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® 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® 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® 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® 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:
* The study reported on in this Stock Exchange Announcement
is the LEAD 3 study.
* 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).
* Results from the LEAD® 1 and LEAD® 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.
* Results from the LEAD® 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