PRINCETON, NJ--(Marketwire - April 23, 2010) - Yesterday, The Lancet published online the results of the first study comparing the once-daily human GLP-1 analog, Victoza® (liraglutide [rDNA] injection) with a DPP-4 inhibitor, Januvia®. The 26-week trial showed that Victoza® produced significantly greater reductions in A1C, fasting plasma glucose (FPG), and body weight than Januvia®, with similar or better overall treatment satisfaction.
In addition, significantly more patients achieved the A1C targets of < 7.0% (American Diabetes Association [ADA]). Nearly twice as many study participants on Victoza® reached the ADA goal compared to the Januvia® group (56% and 44% in the 1.8mg and 1.2mg Victoza® groups versus 22% in the Januvia® group).
"These data clearly show that Victoza® at both doses was more effective than Januvia® at achieving blood sugar control in people with type 2 diabetes with the benefit of weight loss," said Dr. Richard Pratley, of the Diabetes and Metabolism Translational Medicine Unit, University of Vermont College of Medicine, Burlington. "With so many patients still struggling to lower their blood sugar, Victoza® represents an effective new option."
About the study
The study was a 26-week, randomized, parallel-group, open-label trial comparing safety and efficacy of the two recommended doses of once-daily Victoza® (1.2mg and 1.8mg) with once-daily Januvia® (100mg), all added to metformin. It was conducted in Europe and North America in 665 people with type 2 diabetes who were not adequately controlled on daily treatment with greater than or equal to 1500mg metformin alone.
Major findings from the study include:
- Victoza® provided superior reductions in A1C versus Januvia® (1.50% and 1.24% respectively for Victoza® 1.8mg and 1.2mg, 0.90% for Januvia®).
- Mean decreases in FPG were significantly greater with Victoza® (2.14mmol/L [38.5mg/dL] and 1.87mmol/L [33.7mg/dL] respectively for Victoza® 1.8mg and 1.2mg, 0.83mmol/L [15.0mg/dL] for Januvia®).
- Victoza® resulted in significantly greater reductions in body weight (3.38kg [7.44lbs] and 2.86kg [6.29lbs] respectively for Victoza® 1.8mg and 1.2mg, 0.96kg [2.11lbs] for Januvia®).
Secondary endpoints included the Diabetes Treatment Satisfaction Questionnaire (DTSQ), a validated measure used in many diabetes trials to measure the change in treatment satisfaction. Improvement in overall treatment satisfaction was significantly greater with Victoza® 1.8mg than Januvia®, and similar between Victoza® 1.2mg and Januvia®. No overall differences in the perceived convenience of treatment (oral versus injection) were reported.
Both Victoza® and Januvia® were well tolerated. Nausea initially occurred at higher rates with Victoza® 1.8mg (27%) and 1.2mg (21%) than Januvia® (5%). However, nausea with Victoza® was transient -- most episodes occurred early with few withdrawals; by later weeks, the prevalence of nausea was similar to that of Januvia®.
Incretin-based diabetes treatments
Victoza® and Januvia® are both incretin-based diabetes therapies. Victoza® is the first once-daily human GLP-1 analog that mimics the activity of the naturally-occurring hormone, GLP-1, while Januvia®, a DPP-4 inhibitor, blocks the enzyme responsible for the breakdown of GLP-1 and other substances.
Consensus statements from the American Diabetes Association and the European Association for the Study of Diabetes, and the American Association of Clinical Endocrinologists, and the American College of Endocrinology recognized GLP-1 analogs as an effective add-on treatment for patients who are not responding to metformin and lifestyle changes alone.
Indications and Usage
Victoza is an injectable prescription medicine that improves blood sugar 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 that is 97% similar to endogenous human 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 also been approved by the European Medicines Agency (EMA) in all 27 European Union member states. As of April 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, France 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
Januvia® is a registered trademark of Merck Sharp & Dohme Corp., a subsidiary of Merck & Co., Inc.
Novo Nordisk Inc. 100 College Road West Telephone: Internet:
Communications Princeton, NJ 609-987-5800 www.novonordisk-us.com
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