Data Analysis Reinforces the Safety Profile of Levemir(R)

* Reuters is not responsible for the content in this press release.

Tue Oct 20, 2009 8:30am EDT

PRINCETON, N.J., Oct. 20 /PRNewswire-FirstCall/ -- A meta-analysis of clinical
data published today in Diabetologia, the medical journal for the European
Association for the Study of Diabetes (EASD), demonstrated that the Novo
Nordisk long-acting insulin Levemir® (insulin detemir [rDNA origin] injection)
was not associated with any increase in the incidence of cancer when compared
to human insulin(1,2). 


The analysis conducted by Novo Nordisk assessed the relative risk of a cancer
diagnosis during clinical treatment with Levemir®. It included approximately
9,000 patients (approximately 5,200 taking Levemir®) in 21 randomized
controlled trials and compared the incidence of cancer in patients treated
with Levemir® with that of patients treated with either human insulin (NPH
insulin) or insulin glargine.  


The data revealed that treatment with Levemir® was associated with a
statistically significantly lower incidence of cancer than with NPH insulin
treatment (0.36 events per 100 patient years in the Levemir® group vs. 0.92
events in the NPH insulin group; p<0.05).


The incidence of cancer during Levemir® treatment was also lower than that
seen during treatment with insulin glargine, but this difference was not
statistically significant (0.87 events per 100 patient years in the Levemir®
group vs. 1.27 events in the insulin glargine group; p>0.05)(3).


"We have designed Levemir® with all aspects of safety for the patient in mind
and these data are in line with what we would expect," said Dr. Alan Moses,
Novo Nordisk Vice President and Chief Medical Officer. "Physicians, health
care providers and patients can continue to feel confident in using Levemir®
to effectively treat type 1 and type 2 diabetes."


The analysis was performed in response to the Diabetologia June publication of
four registry studies(4). Those studies, while inconclusive due to
methodological limitations, suggested a potential link between another
long-acting insulin analog, insulin glargine, and cancer.  As a basis for such
a possible link, an accompanying editorial explained that certain insulin
analogs have a structure making them more likely to bind to the IGF-1 receptor
which is known to be involved in promoting tumor growth(5).


The full text of the manuscript can be found online at
http://www.diabetologia-journal.org.




(1) DIABETOLOGIA ONLINE: Dejgaard A et al. No evidence of increased risk of
malignancies in patients treated with insulin detemir: a meta-analysis.
www.diabetologia-journal.org
(2) Novo Nordisk data on file, presented at the EASD on 1 October 2009, to be
published
(3) A meta-analysis is a systematic method that uses statistical techniques
for combining results from different studies to obtain a quantitative estimate
of the overall effect of a particular intervention or variable on a defined
outcome. This combination may produce a stronger conclusion than can be
provided by any individual study. Source: National Information Center on
Health Services Research and Health Care Technology (NICHSR).
http://www.nlm.nih.gov/nichsr/hta101/ta101014.html
(4) www.diabetologia-journal.org
(5) Kurtzhals P, Schaffer L, Sorensen A, Kristensen C, Jonassen I, Schmid C,
Trub T (2000): Correlations of receptor binding and metabolic and mitogenic
potenticies of insulin analogs designed for clinical use. Diabetes 49:
999-10055.


About Levemir® 
Levemir® (insulin detemir [rDNA origin] injection) is a man-made long-acting
insulin that is used to control high blood sugar in adults and children with
diabetes mellitus. 


Important Safety Information: 
Do not take Levemir® if your blood sugar is too low (hypoglycemia) or if you
are allergic to anything in Levemir®.  If you take too much Levemir® your
blood sugar may fall too low. 


Check your blood sugar levels. Ask your health care provider what your blood
sugars should be and when you should check your blood sugar levels. Alcohol,
including beer and wine, may affect your blood sugar when you take Levemir®.


Do not change the type of insulin you use unless told to do so by your health
care provider. The amount of insulin you take as well as the best time for you
to take your insulin may need to change if you take a different type of
insulin. 


Never mix Levemir® with other insulin products or use in an insulin pump. 


Needles and Levemir® FlexPen® must not be shared.


Tell your health care provider about all medicines you take and all of your
medical conditions, including if you are pregnant or breastfeeding. Your
Levemir® dose may change if you take other medicines.


The most common side effect of Levemir® is low blood sugar (hypoglycemia).
Other possible side effects include reactions at the injection site (like
redness, swelling and itching), and allergic reactions. Get medical help right
away if you experience signs of serious allergic reaction such as body rash,
trouble with your breathing, fast heartbeat, or sweating. Ask your doctor or
pharmacist for further information.


For full prescribing information, visit http://www.levemir-us.com.


Levemir® is a registered trademark of Novo Nordisk A/S.


Novo Nordisk is a healthcare company with an 86-year history of innovation and
achievement 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 to diabetes care, Novo Nordisk
has a leading position within areas such as hemostasis management, growth
hormone therapy, and hormone therapy for women. Novo Nordisk's business is
driven by the Triple Bottom Line: a commitment to economic success,
environmental soundness, and social responsibility to employees and customers.
With headquarters in Denmark, Novo Nordisk employs more than 26,000 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 global
information, visit novonordisk.com; for United States information, visit
www.novonordisk-us.com.




SOURCE  Novo Nordisk

Media (in the U.S.), Ambre Morley, +1-609-987-5898, or Investors, Hans Rommer,
+1-609-919-7937, both for Novo Nordisk
Comments (0)
This discussion is now closed. We welcome comments on our articles for a limited period after their publication.