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New Study Results Show That Patients Have Higher Treatment Satisfaction With Liraglutide Compared to Exenatide

Montreal (ots/PRNewswire)

New data on patient
treatment satisfaction from the LEAD(TM) 6 trial  presented on the
22nd October at the 20th World Diabetes Congress  (International
Diabetes Federation) shows that patients have higher overall
treatment satisfaction with liraglutide than they do with
exenatide.[1]
To view the Multimedia News Release, please click:
http://multivu.prnewswire.com/mnr/prne/novo/37559/
Specifically, among the 379 patients who completed the Diabetes
Treatment Satisfaction Questionnaires (DTSQ) during the LEAD(TM) 6
trial, those taking liraglutide perceived less hypoglycaemia
(abnormally low blood sugar levels) or hyperglycaemia (abnormally
high blood sugar levels) compared to those on exenatide.[1]
"Liraglutide has shown here in a convincing study that it is
associated with less nausea, less perceived hypoglycaemia and
definitely higher patient satisfaction compared to exenatide," said
Dr Wolfgang Schmidt, professor and chair of the Department of
Medicine at St. Josef-Hospital and one of the principal investigators
in the trial.
"Patient-reported outcomes data is an important extension of the
efficacy data. If a patient is satisfied with his or her treatment,
then they are much more likely to really stick to the treatment over
the long term, which is necessary in type 2 diabetes," Dr Schmidt
noted.
Treatment satisfaction was also evaluated during an open-label
extension of the LEAD(TM) 6 trial, in which patients were either
switched from exenatide to liraglutide or continued on liraglutide
for another 14 weeks. These results show that switching patients from
exenatide to liraglutide further improves patient satisfaction, as
evidenced by the larger rise in DTSQs scores for switched patients
compared to those who continued on liraglutide from weeks 26-40.
Other key liraglutide data at IDF Congress
Two separate meta-analyses of all six LEAD(TM) (Liraglutide
Effect and Action in Diabetes) trials were also presented at the
congress. Meta-analyses are a type of statistical analysis that
summarise the results for a given treatment from several different
studies in order to evaluate its overall effect on a specific
outcome.
The meta-analyses presented at the congress documented:
1) Liraglutide's positive effect on lipid profile in patients
with type 2 diabetes[2] and 2) liraglutide's ability to lower both
HbA1C and weight without inducing hypoglycaemia versus that of the
other active comparators in the LEAD(TM) programme including
exenatide, glimepiride, rosiglitazone and insulin glargine.[3] Each
of the meta-analyses comprised 3,967 people with type 2 diabetes.
In the lipid meta-analysis, total cholesterol, low density
lipoprotein, free fatty acids and triglycerides were all
statistically significantly reduced from baseline with liraglutide
over 26 weeks of treatment. Furthermore, total cholesterol and low
density lipoproteins were significantly reduced with liraglutide
treatment compared to rosiglitazone, glimepiride or insulin
glargine.[2]
In the meta-analysis evaluating efficacy on combined treatment
targets of HbA1c and weight without hypoglycaemia, more patients in
the liraglutide group reached HbA1c<7.0% with no weight gain or
hypoglycaemia than those on comparator treatments. Patients were more
likely to reach these treatment goals without hypoglycaemia on
liraglutide compared to other commonly used diabetes treatments.[3]
LEAD(TM) 6 trial, extension and sub-analysis designs
LEAD(TM) 6 was a 26-week, open-label trial of 464 patients with
type 2 diabetes and HbA1c levels between 7-11%, who were randomised
to once-daily liraglutide or twice-daily exenatide on a metformin
plus or minus sulphonylurea therapy background. Results from this
direct comparison trial were published in The Lancet.[4]
In the LEAD(TM) 6 extension trial, patients were either switched
from exenatide to liraglutide or continued on liraglutide for a
period of 14 weeks. All 389 patients who completed the randomised
trial entered into the extension phase.[5]
In the patient-reported outcomes analysis, a subgroup of 379
patients had treatment satisfaction evaluated using two versions of
the Diabetes Treatment Satisfaction Questionnaire: status (DTSQs) at
baseline and week 26, and change (DTSQc) at week 26. Patients had
higher overall treatment satisfaction with liraglutide than they did
with exenatide and, in particular, their perception of hyperglycaemia
and hypoglycaemia was reduced more by liraglutide than by exenatide.
In the 14-week extension, 313 patients answered the DTSQs at
weeks 34 and 40 and the DTSQc at week 34. These results showed that
switching patients from exenatide to liraglutide further improves
patient satisfaction, as evidenced by the larger rise in treatment
satisfaction scores for switched patients compared to those who
continued on liraglutide from weeks 26-40.[1]
About Victoza(R)
Victoza(R) is a human glucagon-like peptide-1 (GLP-1) analogue
developed for the treatment of type 2 diabetes. Victoza(R) lowers
blood glucose by stimulating the release of insulin when blood sugar
levels are high and also by slowing gastric emptying. Victoza(R) also
reduces body weight and body fat mass through mechanisms involving
reduced hunger and lowered energy intake.
The European Commission granted marketing authorisation for
Victoza(R) on 30 June 2009 for all 27 European Union member states
and it is already on the market in Germany, the UK and Denmark.
According to this authorisation, Victoza(R) is indicated for the
treatment of adults with type 2 diabetes mellitus to achieve
glycaemic control:
- in combination with metformin or a sulphonylurea in patients with
      insufficient glycaemic control despite maximal tolerated dose of
      monotherapy with metformin or sulphonylurea, and
    - in combination with metformin and a sulphonylurea or metformin and a
      thiazolidinedione in patients with insufficient glycaemic control
      despite dual therapy.
Multimedia press release:
To view an online version of this press release, including video
comments from Dr Wolfgang Schmidt, Professor of Medicine, St Josef
Hospital Ruhr-Bochum University, Germany, Dr Bernard Zinman,
Director, Leadership Sinai Centre for Diabetes, Professor of
Medicine, University of Toronto, Canada and Dr Mads Krogsgaard
Thomsen, Chief Science Officer, Novo Nordisk, Copenhagen, please
visit, http://multivu.prnewswire.com/mnr/prne/novo/37559/
For more information on Victoza(R), please visit
http://www.novonordisk.com/victoza-pressroom
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 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 28,500
employees in 81 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
http://www.novonordisk.com.
References
[1] Christiansen et al. Improved patient-reported outcomes
following treatment for type 2 diabetes with liraglutide compared
with exenatide, in addition to metformin, sulphonylurea or both, 20th
World Diabetes Congress 18-22 Oct 2009, Montreal, CAN; Abstract
P-1403.
[2] Plutzky et al. Reductions in lipids and CV risk markers in
T2D patients treated with liraglutide: a meta-analysis. 20th World
Diabetes Congress 18-22 Oct 2009, Montreal, CAN; Abstract O-0542.
[3] Zinman et al. Impact of liraglutide on reaching target HbA1C
without weight gain or hypoglycaemia, versus other T2D therapies.
20th World Diabetes Congress 18-22 Oct 2009, Montreal, CAN; Abstract
D-0910.
[4] Buse J et al. A switch from twice-daily exenatide to
once-daily liraglutide further improves glycaemic control in patients
with type 2 diabetes on oral patients. Diabetologia 2009; 52 (Suppl.
1): Abstract 2.
[5] Buse J, Rosenstock J, Sesti G, Schmidt WE, Montanya E, Brett
J, Zychma M, Blonde L for the LEAD 6 study group. Liraglutide once a
day versus exenatide twice a day for type 2 diabetes: a 26-week
randomised, parallel-group, multinational, open-label trial (LEAD-6).
Lancet 2009; 374 (9683): 39-47.

Contact:

Further information: Media: Katrine Sperling, Tel: +45-44426718,
krsp@novonordisk.com; In North America: An Phan, Tel:
+1-609-558-0420, anph@novonordisk.com; Investors: Mads Veggerby
Lausten, Tel: +45-4443-7919, mlau@novonordisk.com; Kasper Roseeuw
Poulsen, Tel: +45-4442-4471, krop@novonordisk.com; In North America:
Hans Rommer, Tel: +1-609-919-7937, hrmm@novonordisk.com

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