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 - 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).
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.
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 25,350 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. 25 / 2007