New phase 3 study shows efficacy and safety of Victoza® (liraglutide [rDNA origin] injection) for the treatment of type 2 diabetes in adults with moderate renal impairment

New phase 3 study shows efficacy and safety of Victoza® (liraglutide [rDNA origin] injection) for the treatment of type 2 diabetes in adults with moderate renal impairment

San Francisco, U.S., 14 June 2014 – Data from a new phase 3 study demonstrated
that once-daily Victoza® (liraglutide [rDNA origin] injection) provided greater glycaemic
control versus placebo with no worsening of renal function in adults with type 2 diabetes
and moderate renal impairment.1,2 The data were presented today at the 74th Annual
Scientific Sessions of the American Diabetes Association (ADA) in San Francisco, CA.
Renal impairment is one of the more challenging and common long-term complications
of diabetes and limits the use of available antidiabetic treatment options.3

The 26-week, double-blind, randomized, controlled study investigated the efficacy and
safety of Victoza® compared with placebo when added to preexisting oral antidiabetic
treatment, insulin or a combination thereof. The study showed that adults with type 2
diabetes and moderate renal impairment, defined as those with stage 3 chronic kidney
disease (eGFR 30-59 mL/min/1.73 m2; MDRD), treated with Victoza® had significantly
greater improvements in mean HbA1c (a measure of blood glucose levels) (-1.05% vs.
-0.38%; ETD -0.66% [95% CI: -0.90;-0.43]; p<0.0001), were more likely to achieve
target HbA1c <7% (52.8% vs. 19.5%; p<0.0001), and experienced significantly greater
weight loss from baseline (-2.41 kg/5.31 lbs vs. -1.09 kg/2.40 lbs; ETD

-1.32 kg/2.90 lbs [95% CI: -2.24;-0.40]; p=0.0052) versus placebo. No worsening of
renal function and a lower incidence of hypoglycaemia with treatment of Victoza®
compared with placebo were observed in the study.1, 2

"Renal impairment is very common in patients with type 2 diabetes, especially in adults
over 65 years of age," said Melanie Davies, Professor of Diabetes Medicine and Honorary
Consultant, Diabetes Research Centre, University of Leicester, U.K. "Of the therapies
available for type 2 diabetes, it is essential we have treatment options for patients with
associated renal impairment."

Overall, there is limited experience with Victoza® (liraglutide [rDNA origin] injection) in
patients with mild, moderate, and severe renal impairment, including end-stage renal
disease. Victoza® should be used with caution in this patient population.
The most common adverse events (AEs) seen in this study were gastrointestinal. These
included nausea (21.4% vs. 4.4% placebo), vomiting (12.1% vs. 2.2%), diarrhoea
(7.1% vs. 2.9%) and constipation (5.7% vs. 1.5%). Additional frequent AEs (≥5%) were
renal impairment (5% vs. 5.8% placebo), nasopharyngitis, usually referred to as the
common cold (5% vs. 11.7%), headache (5% vs. 2.9%), increased lipase (15% vs.
8.8%) and decreased glomerular filtration rate (6.4% vs. 5.1%).

About the study
The phase 3 study was a multinational study involving 277 adults. People with moderate
renal impairment were defined as those with stage 3 chronic kidney disease. Participants
were randomised to either Victoza® 1.8 mg, the highest dosage available, or placebo as
add-on to existing oral antidiabetic treatment and/or insulin therapy. The mean age of
participants was 68 years old and 66.3 for people treated with Victoza® or placebo,
respectively. The primary endpoint was percentage change in HbA1c from baseline. Other
endpoints included HbA1c to target <7% and body weight change from baseline. Renal
function was measured by estimated glomerular filtration rate (eGFR) change from
baseline.

About Victoza®
Victoza® is a human glucagon-like peptide-1 (GLP-1) analog that was approved by the
U.S. Food and Drug Administration on January 25, 2010, as an adjunct to diet and
exercise to improve blood sugar control in adults with type 2 diabetes.
As of January 2014, Victoza® has been commercially launched in 68 countries globally
including the U.S., Canada, Japan, U.K., Germany, France, Italy, Denmark, Hungary,
Russia, India, Brazil, Mexico, Argentina, Malaysia, and China, as well as a number of
other countries, and will be available in other markets throughout 2014.

About Novo Nordisk
Headquartered in Denmark, Novo Nordisk is a global healthcare company with more than 90 years of
innovation and leadership in diabetes care. The company also has leading positions within haemophilia
care, growth hormone therapy and hormone replacement therapy. Novo Nordisk employs approximately
40,000 employees in 75 countries, and markets its products in more than 180 countries. For more
information, visit novonordisk.com.

Indications and Usage:
Victoza® (liraglutide [rDNA origin] injection) is an injectable prescription medicine that
may improve blood sugar (glucose) in adults with type 2 diabetes when used along with
diet and exercise.
Victoza® is not recommended as the first medication to treat diabetes. Victoza® has not
been studied in patients with history of inflammation of the pancreas (pancreatitis).
Victoza® is not a substitute for insulin and has not been studied in combination with
prandial (mealtime) insulin. Victoza® is not for people with type 1 diabetes or people
with diabetic ketoacidosis. It is not known if Victoza® (liraglutide [rDNA origin] injection)
is safe and effective in children. Victoza® is not recommended for use in children.

Important Safety Information:
In animal studies, Victoza® caused thyroid tumors—including thyroid cancer—in
some rats and mice. It is not known whether Victoza® causes thyroid tumors or
a type of thyroid cancer called medullary thyroid cancer (MTC) in people, which
may be fatal if not detected and treated early. Do not use Victoza® if you or any
of your family members have a history of MTC or if you have Multiple Endocrine
Neoplasia syndrome type 2 (MEN 2). While taking Victoza®, tell your doctor if
you get a lump or swelling in your neck, hoarseness, trouble swallowing, or
shortness of breath. These may be symptoms of thyroid cancer.

Do not use Victoza® if you are allergic to liraglutide or any of the ingredients in Victoza®.
Serious allergic reactions can happen with Victoza®. If symptoms of serious allergic
reactions occur, stop taking Victoza® and seek medical attention. Pancreatitis may be
severe and lead to death. Before taking Victoza®, tell your doctor if you have had
pancreatitis, gallstones, a history of alcoholism, or high blood triglyceride levels since
these medical conditions make you more likely to get pancreatitis.

Stop taking Victoza® and call your doctor right away if you have pain in your stomach
area that is severe and will not go away, occurs with or without vomiting, or is felt going
from your stomach area through to your back. These may be symptoms of pancreatitis.
Before using Victoza®, tell your doctor about all the medicines you take, especially
sulfonylurea medicines or insulin, as taking them with Victoza® may affect how each
medicine works. If you use Victoza® with insulin, you may give both injections in the
same body area (for example, your stomach area), but not right next to each other.
Also tell your doctor if you have severe stomach problems such as slowed emptying of
your stomach (gastroparesis) or problems with digesting food; have or have had kidney
or liver problems; have any other medical conditions; or are pregnant or plan to become
pregnant. Tell your doctor if you are breastfeeding or plan to breastfeed. It is unknown if
Victoza® will harm your unborn baby or if Victoza® passes into your breast milk.
Your risk for getting hypoglycaemia, or low blood sugar, is higher if you take Victoza®
with another medicine that can cause low blood sugar, such as a sulfonylurea or insulin.
The dose of your sulfonylurea medicine or insulin may need to be lowered while taking
Victoza®.

Victoza® may cause nausea, vomiting, or diarrhea leading to dehydration, which may
cause kidney failure. This can happen in people who have never had kidney problems
before. Drinking plenty of fluids may reduce your chance of dehydration.
The most common side effects with Victoza® include headache, nausea, and diarrhea.
Nausea is most common when first starting Victoza®, but decreases over time in most
people. Immune system related reactions, including hives, were more common in people
treated with Victoza® (liraglutide [rDNA origin] injection) compared to people treated
with other diabetes drugs in medical studies.
Please click here for Prescribing Information and Medication Guide.
Further Information
Media:
Katrine Sperling +45 4442 6718 [email protected]
Michael Bachner (U.S.) +1 609 664 7308 [email protected]
Investors:
Kasper Roseeuw Poulsen +45 3079 4303 [email protected]
Jannick Lindegaard Denholt +45 3079 8519 [email protected]
Lars Borup Jacobsen +45 3075 3479 [email protected]
Daniel Bohsen +45 3079 6376 [email protected]
Frank Daniel Mersebach (US) +1 609 235 8567 [email protected]
References
1 Davies M, Atkin S, Bain S, Rossing P, Scott D, et al. Efficacy and Safety of Liraglutide versus
Placebo as Add-on to Existing Diabetes Medication in Subjects with Type 2 Diabetes (T2DM) and
Moderate Renal Impairment (LIRA-RENAL). Guided Audio Poster Tour 0965-P at 74th Scientific
Sessions of the American Diabetes Association (ADA), 15 June 2014.
2 Efficacy and Safety of Liraglutide versus Placebo as Add-on to Existing Diabetes Medication in
Subjects with Type 2 Diabetes (T2DM) and Moderate Renal Impairment (LIRA-RENAL). Submitted
to 74th Scientific Sessions of the American Diabetes Association (ADA), 15 June 2014.
3Suarez M, Thomas D, Barisoni L, Fornoni A. Diabetic nephropathy: Is it time yet for routine kidney
biopsy? World Journal of Diabetes 2013; 4(6): 245-255c.

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