New one-year data of IDegLira shows glucose-lowering effect was maintained for people with type 2 diabetes
San Francisco, U.S., 14 June 2014 – New Phase 3a findings show IDegLira, the
investigational once-daily single injection combination of insulin degludec and liraglutide,
for the treatment of people with type 2 diabetes, maintained its glucose-lowering effect
and confirmed safety evaluations for up to one year.1 Findings from the 26-week
extension of the DUAL™ I clinical trial programme were presented today at the 74th
Annual Scientific Sessions of the American Diabetes Association (ADA) in
San Francisco, CA.
The DUAL™ I extension trial compared the efficacy and safety of IDegLira with insulin
degludec and liraglutide 1.8 mg alone in insulin-naïve adults with type 2 diabetes
uncontrolled on metformin with or without pioglitazone. At 52 weeks, IDegLira
demonstrated a statistically significant and sustained HbA1c (blood glucose) reduction of
1.8% from baseline versus 1.4% for insulin degludec and 1.2% for liraglutide
(p<0.0001). The average HbA1c at the end of the trial was 6.4% for IDegLira, 6.9% with
insulin degludec and 7.1% with liraglutide. Of the patients on IDegLira, 78% achieved an
HbA1c goal of <7% versus 63% for insulin degludec and 57% for liraglutide. Mean fasting
plasma glucose (FPG) was similar for IDegLira (103 mg/dl) and insulin degludec (108
mg/dl) and higher for liraglutide (132 mg/dl).1
"Maintaining glycaemic control as diabetes progresses is an ongoing problem as patients
fear initiating new therapies that may increase the risk of side effects such as weight gain
and hypoglycaemia," said Professor John Buse, University of North Carolina School of
Medicine, Chapel Hill, North Carolina, U.S. "All of the IDegLira data presented here at
ADA indicate that this treatment can address these patient concerns."
At the end of the trial, the IDegLira treatment group observed a mean weight reduction
of 0.4 kg (0.9 lbs), which was consistent with the first 26 weeks of treatment. Patients
taking insulin degludec had a weight gain of 2.3 kg (5.1 lbs) and patients on liraglutide
had a weight reduction of 3.0 kg (6.6 lbs). The estimated treatment difference between
IDegLira and insulin degludec was -2.8 kg (-6.1 lbs) and the relative treatment difference
between IDegLira and liraglutide was 2.7 kg (5.9 lbs).1
The daily insulin dose for patients on IDegLira remained stable throughout the extension
phase (39 units) compared with insulin degludec (62 units). Patients treated with
IDegLira had a 37% lower rate of hypoglycaemia versus insulin degludec (p<0.0001)
whereas liraglutide was associated with less hypoglycaemia.1
Also during the scientific meeting, additional findings from two analyses based on the 52-
week DUAL™ I and 26-week DUAL™ II trials were presented:
1. Impact of BMI on HbA1c Reduction, Hypoglycemia Rates and Insulin
Requirements in Response to IDegLira in Patients With Type 2 Diabetes
(Abstract #0066-OR; presented by John Buse)2
2. IDegLira Efficacy Across the Range of Disease Progression in Type 2 Diabetes
(Abstract #0067-OR; presented by Helena Rodbard)3
More information on those studies is available upon request.
The most frequently occurring adverse events (≥5%) seen at the conclusion of the
DUAL™ I extension trial for IDegLira, insulin degludec and liraglutide were diarrhoea
(10.2%, 6.8%, 16.3%); nausea (10.3%, 3.9%, 22.3%); vomiting (5%, 2.4%, 9.2%);
headache (12.8%, 10.9%, 14.6%); nasopharyngitis, usually referred to as the common
cold (13.9%, 12.6%, 13.3%); increased lipase (5.8%, 4.4%, 8.5%); and decreased
appetite (2.7%, 0.5%, 7.3%), respectively.4
About the DUAL™ clinical programme
DUAL™ (DUal Action of Liraglutide and Insulin Degludec in Type 2 Diabetes) consists of
two phase 3a trials encompassing more than 2,000 people with type 2 diabetes.
DUAL™ I (1,663 people) – a 26-week, randomised, parallel, three-arm, open-label,
multicentre, trial conducted at 271 sites across 19 countries. The trial compared the
efficacy and safety of IDegLira versus insulin degludec and liraglutide alone, in insulinnaïve
adults with type 2 diabetes uncontrolled with metformin with or without
pioglitazone. A 26-week extension phase of the main trial was conducted to generate
longer-term safety and efficacy data. The topline results from the main period were
reported in 2012.
DUAL™ II (398 people) – a 26-week, randomised, parallel, two-arm, double-blinded,
multicentre, trial conducted at 75 sites across seven countries. The trial compared the
efficacy and safety of IDegLira and insulin degludec once daily, both added on to
metformin in adults with type 2 diabetes uncontrolled on basal insulin (20–40 units) in
combination with metformin with or without sulfonylurea/glinides. Sulfonylureas and
glinides were discontinued at randomisation. In this trial, the allowed maximum dose of
insulin degludec in the treatment arms was 50 units so as to be able to demonstrate the
contribution of the liraglutide component of IDegLira on glycaemic control. The topline
results were reported in 2012.
About IDegLira
IDegLira, which is being developed for the treatment of type 2 diabetes, is a combination
of insulin degludec, a once-daily basal insulin analogue with an ultralong duration of
action, and liraglutide, a once-daily human GLP-1 analogue for the treatment of type 2
diabetes. IDegLira is being investigated in the Phase 3 DUAL™ clinical trial programme.
Novo Nordisk submitted the regulatory filing for IDegLira in the EU on 31 May 2013.
Insulin degludec has received regulatory approval and is marketed as Tresiba® in many
countries including Argentina, Aruba, Bangladesh, Brazil, Chile, El Salvador, the EU,
Iceland, India, Japan, Lebanon, Liechtenstein, Macedonia, Mexico, Norway, Russia and
Switzerland. Insulin degludec is currently under review by the U.S. Food and Drug
Administration.
About Victoza® (liraglutide [rDNA origin] injection)
Victoza® is a human glucagon-like peptide-1 (GLP-1) analogue 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.
Indications and Usage:
Victoza® 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® 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® (liraglutide [rDNA origin] injection) 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 hypoglycemia, 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® compared to people treated with other diabetes drugs in medical
studies.
Please click here for Prescribing Information and Medication Guide.
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.
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 (U.S.) +1 609 235 8567 [email protected]
References
1. Gough S, et al. One-year efficacy and safety of IDegLira in patients with type 2
diabetes. Oral presentation (0065-OR) at the 74th Scientific Sessions of the
American Diabetes Association (ADA), 14 June 2014.
2. Buse J, et al. Impact of BMI on HbA1c reduction, hypoglycemia rates and insulin
requirements in response to IDegLira in patients with type 2 diabetes. Oral
presentation (0066-OR) at the 74th Scientific Sessions of the American Diabetes
Association (ADA), 14 June 2014.
3. Rodbard HW, et al. IDegLira is efficacious across the range of disease progression
in type 2 diabetes. Oral presentation (0067-OR) at the 74th Scientific Sessions of
the American Diabetes Association (ADA), 14 June 2014.
4. Novo Nordisk. Data on File.
Tresiba® and Victoza® are registered trademarks of Novo Nordisk A/S.
© 2014 Novo Nordisk All rights reserved. 0514-00021252-1 June 2014