PRINCETON, N.J., May 6 Novo Nordisk (NVO) announced today details of the company's cardiovascular outcomes trial for VictozaŽ (liraglutide [rDNA origin] injection), which is set to start in the autumn of 2010.
The trial named LEADER(TM) (Liraglutide Effect and Action in Diabetes: Evaluation of Cardiovascular Outcome Results) aims to assess and confirm the cardiovascular safety of the company's new once-daily human GLP-1 analog VictozaŽ. The trial satisfies the new FDA guideline for type 2 diabetes treatments.
The protocol of this trial has been designed in close collaboration with an international expert Steering Committee, as well as U.S. and EU regulatory authorities, and with assistance from the Population Health Research Institute (PHRI) at McMasters University, Canada. Furthermore, an independent Data Monitoring Committee (DMC) will monitor progress of the trial and ensure that it meets the highest standards of ethics and subject safety.
"There is a well-established association between cardiovascular disease (CVD) and type 2 diabetes," says Dr. John Buse, Chief of Endocrinology and Director of the Diabetes Care Center at the University of North Carolina School of Medicine, and Chairman of the LEADER(TM) Steering Committee. "In fact, CVD ranks as the major cause of death in diabetes, accounting for 50% of all diabetes fatalities. As a result there is a serious unmet need for further long-term studies to help assess the risk of CVD in patients with type 2 diabetes."
The vast majority of people with type 2 diabetes suffer from a range of co-morbidities such as obesity, hypertension, and dyslipidemia. The high prevalence of co-morbidities in combination with hyperglycemia are likely contributors to the increased risk of CVD complications in adults with type 2 diabetes. Yet only 10% of diabetes patients have good control of blood sugar, hypertension and dyslipidemia.
In addition to the underlying link between CVD and type 2 diabetes, some diabetes treatments may be associated with increase in CVD risk. As such, the FDA often requires additional studies to determine that type 2 diabetes drugs do not further increase CVD risk.
LEADER(TM) is a long-term, multicenter, international, randomized, double-blind, placebo-controlled, phase 3b trial that will aim to enroll about 9,000 patients who will be treated for up to five years.
The trial will compare VictozaŽ added to standard of care with standard of care alone in people with type 2 diabetes.
VictozaŽ is the first and only human GLP-1 analog with 97% homology to native GLP-1. Like native GLP-1, VictozaŽ works by stimulating the beta cells to release insulin only when blood glucose levels are high. Due to this glucose-dependent mechanism of action, VictozaŽ is associated with a low rate of hypoglycemia. The mechanism of blood glucose lowering also involves a delay in gastric emptying.
VictozaŽ was evaluated in the Liraglutide Effect and Action in Diabetes (LEAD) phase 3 trials, the most comprehensive clinical development program conducted to date by Novo Nordisk Inc. in type 2 diabetes. In clinical studies including use as monotherapy and in combination with standard diabetes treatments, VictozaŽ produced significant reductions in A1C and also was associated with weight loss.
Indications and Usage
VictozaŽ is an injectable prescription medicine that improves blood sugar (glucose) in adults with type 2 diabetes when used with a diet and exercise program.
VictozaŽ is not recommended as the first medication to treat diabetes. VictozaŽ is not insulin and has not been studied in combination with insulin. VictozaŽ is not for people with type 1 diabetes or people with diabetic ketoacidosis. It is not known if VictozaŽ is safe and effective in children. VictozaŽ is not recommended for use in children.
Important Safety Information
In animal studies, the medicine in VictozaŽ caused thyroid tumors - including thyroid cancer - in some rats and mice. It is not known whether VictozaŽ 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 VictozaŽ 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 VictozaŽ, tell your doctor if you get a lump or swelling in your neck, hoarseness, trouble swallowing, or shortness of breath. These may be signs of thyroid cancer.
Inflammation of the pancreas (pancreatitis) may be severe and lead to death.
Before taking VictozaŽ, 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 VictozaŽ 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 VictozaŽ, tell your doctor about all the medications you take, especially sulfonylurea medicines or insulin, as taking them with VictozaŽ may affect how each medicine works.
Also tell your doctor if you are allergic to any of the ingredients in VictozaŽ; 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; are pregnant or plan to become pregnant. Tell your doctor if you are breastfeeding or plan to breastfeed. It is unknown if VictozaŽ will harm your unborn baby or if VictozaŽ passes into your breast milk.
Your risk for getting hypoglycemia, or low blood sugar, is higher if you take VictozaŽ with another medicine that can cause low blood sugar, such as a sulfonylurea. The dose of your sulfonylurea medicine may need to be lowered while taking VictozaŽ.
The most common side effects with VictozaŽ include headache, nausea, diarrhea, and resistance to liraglutide (antibody formation). Nausea is most common when first starting VictozaŽ, but decreases over time in most people. Immune system related reactions, including hives, were more common in people treated with VictozaŽ compared to people treated with other diabetes drugs in medical studies.
For more information, ask your healthcare provider or pharmacist.
For full prescribing information, please go to Victoza.com or call 1-877-VICTOZAŽ (1-877-484-2869)
Novo Nordisk is a global healthcare company with more than 87 years of innovation and leadership in diabetes care. The company also has leading positions within hemophilia care, growth hormone therapy and hormone therapy for women. Novo Nordisk's business is driven by the Triple Bottom Line: a commitment to social responsibility to employees and customers, environmental soundness and economic success. Headquartered in Denmark, Novo Nordisk employs more than 29,000 employees in 81 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 (NVO). For more information, visit novonordisk-us.com.
SOURCE Novo Nordisk