June 06, 2008 12:25 ET
Clinical study shows liraglutide provides statistically significantly better blood glucose control than exenatide
BAGSVÆRD, DENMARK--(Marketwire - June 6, 2008) - Novo Nordisk today announced headline clinical results from a phase 3
clinical study (LEAD™ 6) comparing the effects of liraglutide, a
once-daily human GLP-1 analogue, with exenatide, a twice-daily GLP-1
analogue. The 26-week study, which is the first study to provide a
direct comparison between the two GLP-1 analogues, included 464
people with type 2 diabetes who were randomised to treatment with
either liraglutide once daily or exenatide twice daily, as add-on to
their existing treatment consisting of metformin, sulfonylurea, or a
combination of both.
The average HbA1c level at the beginning of the study was slightly
above 8% and the primary endpoint was the change in HbA1c. Patients
treated with liraglutide achieved a reduction in HbA1c of more than
1.1 percentage points, compared to a reduction in HbA1c of less than
0.8 percentage points in the exenatide group, a difference which was
statistically significant. Liraglutide treatment led to statistically
significantly more patients achieving both the American Diabetes
Association (ADA) and American Association of Clinical
Endocrinologists (AACE) HbA1c targets of < 7% and < = 6.5%,
respectively. Specifically, close to 55% of patients in the
liraglutide group reached the ADA target, compared to close to 45% in
the exenatide group. Likewise, around 35% of patients treated with
liraglutide achieved the AACE target, compared to around 20% for
patients treated with exenatide.
The patients' average weight at the beginning of the study was
between 90 and 95 kg. Both patients treated with liraglutide and
patients treated with exenatide lost on average around 3 kg during
the course of the study, with a trend towards more weight loss in the
liraglutide group. Among patients previously treated with metformin
alone, this difference was 1 kg in favour of liraglutide (not
The most frequently reported adverse event for both liraglutide and
exenatide was nausea at a level of around 25% (percent of all study
participants reporting nausea at least once). In the liraglutide
group, the percentage of patients reporting nausea in each week fell
to low single-digit numbers after 8-10 weeks, similar to the level
observed in a background population. In the exenatide group, the
level after 8-10 weeks of treatment remained at the level of 10%.
As expected, the overall rate of hypoglycaemia in the study was low.
The rate of minor hypoglycaemia was statistically significantly lower
in the liraglutide group, compared to the exenatide group.
Mads Krogsgaard Thomsen, executive vice president and chief science
officer of Novo Nordisk, said: "We are very encouraged by the fact
that the study showed that once-daily liraglutide leads to
statistically significantly better blood glucose control than
twice-daily exenatide. In addition, liraglutide treatment leads to
weight loss and is associated with a very low risk of hypoglycaemia."
The results of the phase 3 trial do not impact Novo Nordisk's
expectations for the company's financial results for 2008, which were
provided on 30 April in connection with the release of the financial
results for the first quarter of 2008.
About liraglutide and HbA1c
Liraglutide is a once-daily human GLP-1 analogue. Liraglutide works
by stimulating the release of insulin only when glucose levels become
too high and by inhibiting appetite. On 23 May 2008, Novo Nordisk
submitted a New Drug Application to the US Food and Drug
Administration as well as a marketing authorisation application to
the European Medicines Agency, for the approval of liraglutide for
the treatment of people with type 2 diabetes.
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
Novo Nordisk is a healthcare company and a world leader in diabetes
care. In addition, Novo Nordisk has a leading position within areas
such as homeostasis 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 26,300
employees in 80 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
Stock Exchange Announcement no 32 / 2008
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