PRINCETON, N.J., March 30 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®. 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.
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LEAD(TM) 6 was a 26-week randomized, open-label study in type 2 diabetes comparing the efficacy and safety of Victoza 1.8 milligrams, once a day + OAD, to exenatide 10 micrograms, twice a day + OAD. In the 14-week extension, patients were switched from exenatide 10 micrograms to Victoza. Exenatide patients were switched to Victoza by titrating the Victoza dose in 0.6 milligram increments weekly to reach the target dose of 1.8 milligrams per day. Patients randomized to Victoza in the initial phase of the study continued on the 1.8 milligram dose.
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"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."
For patients switched to the Victoza 1.8 milligram group, mean A1C decreased from 7.2% at week 26 to 6.9% at week 40 (-0.32 +/-0.043%). A greater percentage of patients reached their A1C targets after switching from exenatide to Victoza (42.5% vs 57.9%). Switched patients also experienced further reductions in fasting plasma glucose (FPG) (0.9 +/-0.16 mmol/L), bodyweight (-1.98 +/-0.33 lbs), and systolic blood pressure (SBP) (-3.8 +/-0.84 mmHg). In those continuing Victoza, reductions in FPG (-0.2 +/-0.11 mmol/L), bodyweight (-0.88 +/-0.33 lbs) and SBP (-2.2 +/-0.88 mmHg) occurred.
Similar numbers of patients reported adverse events in the extension. The most common adverse events reported were diarrhea and nausea.
About LEAD 6 Study Extension
The LEAD 6 extension assessed the efficacy and safety of switching from exenatide twice-daily (10 micrograms) to Victoza once-daily (1.8 milligrams) in patients with type 2 diabetes. Patients were treated previously with metformin and/or a sulphonylurea. After the initial 26-week randomized, double-blind, open-label trial, patients were enrolled in the 14-week extension. All 389 patients who completed the 26-week trial entered the extension period.
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.
Victoza is not insulin. It is not known if Victoza is safe and effective when used with insulin. Victoza is not for people with type 1 diabetes or people with diabetic ketoacidosis. Victoza is not recommended for use in children.
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.
You should tell your healthcare provider if you get a lump or swelling in your neck, hoarseness, difficulty swallowing, or shortness of breath while you are taking Victoza because these may be symptoms of thyroid cancer.
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.
Stop taking Victoza and call your healthcare provider right away if you have pain in your stomach area (abdomen) that is severe and will not go away. The pain may happen with or without vomiting. The pain may be felt going from your abdomen through to your back. These may be symptoms of pancreatitis.
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.
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.
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.
About Victoza
Victoza is the first and only human GLP-1 analog with 97% homology to natural GLP-1. Like natural GLP-1, Victoza (liraglutide [rDNA origin] injection) works by stimulating the beta cells to release insulin only when blood sugar levels are high. Due to this glucose-dependent mechanism of action, Victoza is associated with a low rate of hypoglycemia. The mechanism of blood sugar lowering also involves a delay in gastric emptying.
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.
For full prescribing information, please go to Victoza.com or call 1-877-4VICTOZA (1-877-484-2869).
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.
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 29,300 employees in 76 countries, and markets its products in 179 countries. Novo Nordisk's B shares are listed on the stock exchange in Copenhagen and its ADRs are listed on the New York Stock Exchange (NVO). For more information, visit novonordisk-us.com.
Victoza® is a registered trademark of Novo Nordisk A/S
SOURCE Novo Nordisk
