PRINCETON, N.J., March 30 /PRNewswire-FirstCall/ -- Diabetes Care published online the results of the Novo Nordisk (NVO) LEAD(TM) 6 extension study, which evaluated the efficacy and safety of switching from exenatide, which is taken twice a day, to once-daily Victoza(R). Results show that when added to oral antidiabetes drugs (OADs), patients who switched from exenatide to Victoza experienced further reductions in A1c and weight loss.
"Because Victoza and exenatide are the only GLP-1 agonists currently available, we were very interested to see if there were clinically meaningful differences in the effect of switching from exenatide to Victoza in people with type 2 diabetes," said Dr. John Buse, chief of endocrinology and director of the Diabetes Care Center at the University of North Carolina School of Medicine, and one of the principal investigators in the study. "Clinical benefits were seen in patients who switched from exenatide to Victoza. The significant improvements in blood sugar lowering and fasting glucose confirm the original findings of the trial regarding the efficacy of Victoza."
Similar numbers of patients reported adverse events in the extension. The most common adverse events reported were diarrhea and nausea.
Indications and Usage
Victoza is an injectable prescription medicine that improves blood sugar (glucose) in adults with type 2 diabetes when used with a diet and exercise program.
Important Safety Information
In animal studies, the medicine in Victoza caused rats and mice to develop thyroid tumors, some of which were cancerous. It is not known whether Victoza causes thyroid tumors or a type of thyroid cancer called medullary thyroid cancer (MTC) in people. MTC may lead to death. 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). This is a disease where people have tumors in more than one gland in their body.
Inflammation of the pancreas (pancreatitis) may be severe and lead to death. Certain medical conditions make you more likely to get pancreatitis. Therefore before taking Victoza, tell your healthcare provider if you have had pancreatitis, stones in your gallbladder (gallstones), a history of alcoholism, or high blood triglyceride levels.
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. The dose of your sulfonylurea medicine may need to be lowered while taking Victoza.
Tell your healthcare provider about all the medicine you take and if you are pregnant or breastfeeding. For more information, ask your healthcare provider or pharmacist.
Victoza was approved by the U.S. Food and Drug Administration (FDA) on January 25, 2010 as an adjunct to diet and exercise to improve blood sugar control in adults with type 2 diabetes.
Victoza has been approved by the European Medicines Agency (EMA) in all 27 European Union member states. As of March 2010, approval has also been granted by the regulatory authorities in Japan, Norway, Mexico, Iceland and Switzerland. Victoza has already been commercially launched in the UK, Germany and Denmark as well as a number of other European countries and will be available in other markets throughout 2010. A New Drug Application was also submitted for approval in China in August 2009. A regulatory decision is pending.
Victoza(R) is a registered trademark of Novo Nordisk A/S