Data Analysis Reinforces the Safety Profile of Levemir
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
CONTACT: Media (in the U.S.), Ambre Morley, +1-609-987-5898,
or
Investors, Hans Rommer, +1-609-919-7937, both for Novo
Nordisk
Web Site: http://www.novonordisk-us.com/
Posted: October 2009
