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SOURCE Novo Nordisk
SAN FRANCISCO, June 14, 2014 /PRNewswire/ --
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. 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).
"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).
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.
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:
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.
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 insulin-naïve 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.
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.
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 http://novonordisk.com.
Tresiba® and Victoza® are registered trademarks of Novo Nordisk A/S.
© 2014 Novo Nordisk All rights reserved. 0514-00021252-1 June 2014
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