Liraglutide improves glucose control and lowers body weight in two
phase 3 studies comprising more than 2,000 patients
Novo Nordisk today announced clinical results from the second and
third of five phase 3 studies with liraglutide - the once-daily human
GLP-1 analogue. The two 26-week studies are part of the LEAD®
(Liraglutide Effect and Action in Diabetes) programme and comprised
2,132 patients in total. The two studies investigated the effect of
different doses of liraglutide in combination with a single oral
antidiabetic drug. Patients inadequately controlled by one or two
oral antidiabetic drugs could enter the studies.
After a run-in period to reach the maximal dose of glimepiride,
patients in the LEAD® 1 study were randomised to treatment with
placebo, rosiglitazone or liraglutide. Likewise, after a run-in
period to reach the maximal dose of metformin, patients in the LEAD®
2 trial were randomised to treatment with placebo, glimepiride or
liraglutide. Consequently, liraglutide treatment in the two studies
represented either add-on to previous monotherapy or substitution of
one oral antidiabetic drug. In both trials, the average HbA1c level
at the beginning of the study was just below 8.5% and the average
body weight was 80 to 90 kg.
In the LEAD® 1 study, liraglutide provided statistically
significantly better glucose control than rosiglitazone. Liraglutide
treatment led to around 40% of patients reaching the American
Diabetes Association goal of HbA1c < 7% at study completion. However,
among the patients that had previously been treated with only a
single oral antidiabetic drug, liraglutide treatment led to more than
50% of patients reaching this goal. These success rates were the
result of an HbA1c reduction of approximately 1 to 1.5 percentage
points. As would be expected from a study in which all patients
received glimepiride treatment, hypoglycaemia related to the degree
of blood glucose control was observed in all study arms.
In the LEAD® 2 study, liraglutide treatment led to an HbA1c
improvement that was similar to that observed in the
glimepiride-treated group and at the highest dose of liraglutide,
more than 40% of patients achieved the HbA1c target of 7%. Among
patients previously treated with a single oral antidiabetic drug,
close to 65% of the patients on this dose reached the target. These
success rates were the result of an HbA1c reduction of between 1 and
1.5 percentage points. In the LEAD® 2 study, liraglutide-treated
patients achieved blood glucose control in the presence of
hypoglycaemia rates similar to placebo, contrasting with the
glimepiride-treated group where hypoglycaemia occurred in a larger
number of patients.
At the end of the LEAD® studies, a weight difference of between 2 and
4 kg in favour of liraglutide was found when compared to
rosiglitazone and glimepiride treatment, respectively.
Liraglutide in combination with glimepiride or metformin was well
tolerated. The most frequently reported adverse event during
liraglutide treatment was nausea at an absolute level of between 5%
and 20% when used in combination with glimepiride and metformin.
Mads Krogsgaard Thomsen, executive vice president and chief science
officer of Novo Nordisk, said: "The encouraging clinical results from
the two new trials confirm the positive effect of liraglutide on
blood glucose control, body weight and hypoglycaemia risk seen in
previous studies and leave us confident that we are on track to
submit for regulatory approval mid-2008."
Novo Nordisk expects to announce headline results from the remaining
two LEAD® studies during the second half of 2007 and 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.
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 24 / 2007