PLAINSBORO, N.J., March 4, 2016 /PRNewswire/ -- Novo Nordisk today announced the top-line results from the LEADER trial, which investigated the cardiovascular safety of Victoza® (liraglutide [rDNA origin] injection) over a period of up to 5 years in more than 9,000 adults with type 2 diabetes at high risk of major adverse cardiovascular events. The trial compared the addition of either Victoza® or placebo to standard of care and met the primary endpoint of showing non-inferiority as well as demonstrated superiority, with a statistically significant reduction in cardiovascular risk. The primary endpoint of the study was defined as the composite outcome of the first occurrence of cardiovascular death, non-fatal myocardial infarction or non-fatal stroke. The superior reduction of major adverse cardiovascular events demonstrated by Victoza® was derived from all three components of the endpoint.
The safety profile of Victoza® in LEADER was generally consistent with previous liraglutide clinical studies.
"People with type 2 diabetes generally have a higher risk of experiencing major adverse cardiovascular events. That's why we are very excited about the results from LEADER, which showed that Victoza®, in addition to helping people with type 2 diabetes control their blood sugar levels, also reduces their risk of major adverse cardiovascular events," said Mads Krogsgaard Thomsen, executive vice president and chief science officer of Novo Nordisk. "LEADER is the largest and longest Novo Nordisk clinical trial to report to date, and we look forward to sharing the detailed results with the medical community and submitting the findings to the regulatory authorities."
The detailed results are planned to be presented at the 76th Scientific Sessions of the American Diabetes Association in June 2016.
Indications and Usage
What is Victoza®?
Victoza® is an injectable prescription medicine that may improve blood sugar (glucose) in adults with type 2 diabetes, and should be used along with diet and exercise.
- Victoza® is not recommended as the first choice of medicine for treating diabetes.
- It is not known if Victoza® can be used in people who have had pancreatitis.
- Victoza® is not a substitute for insulin and is not for use in people with type 1 diabetes or people with diabetic ketoacidosis.
- It is not known if Victoza® can be used with mealtime insulin.
- It is not known if Victoza® is safe and effective for use in children.
Important Safety Information
What is the most important information I should know about Victoza® (liraglutide [rDNA origin] injection)?
Victoza® may cause serious side effects, including:
- Possible thyroid tumors, including cancer. Tell your health care provider if you get a lump or swelling in your neck, hoarseness, trouble swallowing, or shortness of breath. These may be symptoms of thyroid cancer. In studies with rats and mice, Victoza® and medicines that work like Victoza® caused thyroid tumors, including thyroid cancer. It is not known if Victoza® will cause thyroid tumors or a type of thyroid cancer called medullary thyroid carcinoma (MTC) in people.
Who should not use Victoza®?
Do not use Victoza® if:
- you or any of your family have ever had a type of thyroid cancer called medullary thyroid carcinoma (MTC) or if you have an endocrine system condition called Multiple Endocrine Neoplasia syndrome type 2 (MEN 2).
- you are allergic to liraglutide or any of the ingredients in Victoza®.
What should I tell my health care provider before using Victoza®?
Before using Victoza®, tell your health care provider if you:
- have or have had problems with your pancreas, kidneys, or liver.
- have any other medical conditions or severe problems with your stomach, such as slowed emptying of your stomach (gastroparesis) or problems with digesting food.
- are pregnant or breastfeeding or plan to become pregnant or breastfeed.
Tell your health care provider about all the medicines you take, including prescription and over-the-counter medicines, vitamins, herbal supplements, and other medicines to treat diabetes, including insulin or sulfonylureas.
How should I use Victoza®?
- Do not mix insulin and Victoza® together in the same injection.
- You may give an injection of Victoza® and insulin in the same body area (such as your stomach area), but not right next to each other.
- Do not share your Victoza® pen with other people, even if the needle has been changed. You may give other people a serious infection, or get a serious infection from them.
What are the possible side effects of Victoza®?
Victoza® may cause serious side effects, including:
- inflammation of your pancreas (pancreatitis). Stop using Victoza® and call your health care provider right away if you have severe pain in your stomach area (abdomen) that will not go away, with or without vomiting. You may feel the pain from your abdomen to your back.
- low blood sugar (hypoglycemia). Your risk for getting low blood sugar may be higher if you use Victoza® with another medicine that can cause low blood sugar, such as a sulfonylurea or insulin. Signs and symptoms of low blood sugar may include: dizziness or lightheadedness, blurred vision, anxiety, irritability or mood changes, sweating, slurred speech, hunger, confusion or drowsiness, shakiness, weakness, headache, fast heartbeat, and feeling jittery.
- kidney problems (kidney failure). In people who have kidney problems, diarrhea, nausea, and vomiting may cause a loss of fluids (dehydration), which may cause kidney problems to get worse.
- serious allergic reactions. Stop using Victoza® (liraglutide [rDNA origin] injection) and get medical help right away if you have any symptoms of a serious allergic reaction including itching, rash, or difficulty breathing.
The most common side effects of Victoza® may include headache, nausea, diarrhea, vomiting, and anti-liraglutide antibodies in your blood.
Victoza® is a prescription medication. Talk to your doctor about the importance of diet and exercise in your treatment plan.
You are encouraged to report negative side effects of prescription drugs to the FDA. Visit www.fda.gov/medwatch, or call 1-800-FDA-1088.
LEADER was a multicenter, international, randomized, double-blind, placebo-controlled trial investigating the long-term effects of Victoza® (1.2 and 1.8 mg) compared to placebo, both in addition to standard of care, in adults with type 2 diabetes at high risk of cardiovascular events. The trial was initiated in September 2010 and randomized 9,340 people with type 2 diabetes from 32 countries who were followed for 3.5–5 years. The primary endpoint was the first occurrence of a composite cardiovascular outcome comprising cardiovascular death, non-fatal myocardial infarction or non-fatal stroke.
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 glycemic control in adults with type 2 diabetes.
As of March 2015, Victoza® has been commercially launched in 75 countries, including the United States, Canada, Japan, United Kingdom, Germany, France, Italy, Denmark, Hungary, Russia, India, Brazil, Mexico, Argentina, Malaysia and China.
In the United States, more than 29 million people are affected by diabetes.1 Type 2 diabetes accounts for 90 to 95 percent of all diabetes cases.2 Diabetes is emerging as one of the most serious health problems of our time; the number of Americans with diabetes has almost quadrupled over the past 30 years.2
About Novo Nordisk
Novo Nordisk is a global healthcare company with more than 90 years of innovation and leadership in diabetes care. This heritage has given us experience and capabilities that also enable us to help people with other serious chronic conditions: hemophilia, growth disorders and obesity. With U.S. headquarters in Plainsboro, N.J., Novo Nordisk Inc. has more than 5,000 employees in the United States. For more information, visit novonordisk.us or follow us on Twitter: @novonordiskus.
1. Centers for Disease Control and Prevention. National Diabetes Statistics Report, 2014. http://www.cdc.gov/diabetes/pubs/statsreport14/national-diabetes-report-web.pdf. Accessed January 19, 2016.
2. Centers for Disease Control and Prevention. Number (in Millions) of Civilian, Noninstitutionalized Adults with Diagnosed Diabetes, United States, 1980–2014. http://www.cdc.gov/diabetes/statistics/prev/national/figpersons.htm. Accessed January 19, 2016.
© 2016 Novo Nordisk All rights reserved. USA16VIM01039 March 2016
SOURCE Novo Nordisk