MEDIA RELEASE PR36724
New Study Results Show That Patients Have Higher Treatment Satisfaction With
Liraglutide Compared to Exenatide
MONTREAL, Oct. 23 /PRNewswire-AsiaNet/ --
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:
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,
For more information on Victoza(R), please visit
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
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under the symbol 'NVO'. For more information,
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.
SOURCE: Novo Nordisk
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