New Data Demonstrates Victoza® (liraglutide [rDNA] injection) Provided Superior and Sustained Blood Sugar Control and Weight Reduction Compared to Januvia® (sitagliptin) at 52 Weeks

ORLANDO, Fla., June 26 /PRNewswire-FirstCall/ -- Poster 16LB -- Late-breaking Novo Nordisk (NVO) extension data presented today at the 70th Annual Scientific Sessions of the American Diabetes Association (ADA) showed that once-daily Victoza® in combination with metformin produced sustained and significantly greater reductions in A1c, body weight and fasting plasma glucose (FPG) than Januvia® plus metformin at 52 weeks.

Key findings from the study include:

• Patients treated with 1.2 mg and 1.8 mg of Victoza® experienced greater reductions in A1c than those treated with Januvia® 100 mg (-1.3% and -1.5% versus -0.9%)
• Victoza® provided greater weight loss versus patients treated with Januvia® (2.8 kg [6.16 lbs] and 3.7 kg [8.14 lbs] for 1.2 mg and 1.8 mg respectively, 1.2 kg [2.64 lbs] for Januvia®)
• Victoza® provided greater change from baseline FPG readings than those treated with Januvia® (-1.7 mmol/L and -2.0 mmol/L for 1.2 mg and 1.8 mg respectively, versus -0.6 mmol/L)
• Patients treated with Victoza® 1.8 mg reported significantly greater treatment satisfaction than those treated with Januvia®

"What is so encouraging about these data is that Victoza® at both doses was more effective than Januvia® at achieving blood sugar control in people with type 2 diabetes over a period of one year.  Patients who began the trial with higher A1c levels achieved greater reductions in A1c with treatment with Victoza®," said Dr. Richard Pratley, of the Diabetes and Metabolism Translational Medicine Unit, University of Vermont College of Medicine, Burlington.  "Although Victoza® is not indicated for the management of obesity, the study showed that Victoza® provided greater weight loss than Januvia®, which is a benefit for those patients struggling to maintain a healthy weight."

In addition, significantly more patients treated with Victoza® achieved the ADA recommended A1c target of <7.0%.  Nearly twice as many study participants on Victoza® reached the ADA goal compared to the Januvia® group (50% and 63% in the 1.2mg and 1.8mg Victoza® groups versus 27% in the Januvia® group).

About the study

This study extension compared the safety and efficacy of the two recommended doses of once-daily Victoza® (1.2 mg and 1.8 mg) with once-daily Januvia® (100mg), all added to metformin.  After the initial 26-week randomized, open-label trial, 497 patients were enrolled in this 26-week extension.  The trial was conducted in Europe and North America in people with type 2 diabetes who were not adequately controlled on metformin alone.

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® 1.8 mg than 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® 1.2 mg (21%) and 1.8 mg (27%) 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® with <2% reporting nausea in weeks 27-52.

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 endogenous, 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 ADA and the European Association for the Study of Diabetes, and the American Association of Clinical Endocrinologists, and the American College of Endocrinology recognize 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 may improve blood sugar (glucose) in adults with type 2 diabetes when used with a diet and exercise program.

Victoza® is not recommended as the first medication to treat diabetes.  Victoza® is not insulin and has not been studied in combination with insulin.  Victoza® is not for people with type 1 diabetes or people with diabetic ketoacidosis.  It is not known if Victoza® is safe and effective in children.  Victoza® is not recommended for use in children.  

Important Safety Information

In animal studies, the medicine in Victoza® caused thyroid tumors – including thyroid cancer - in some rats and mice.  It is not known whether Victoza® 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 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).  While taking Victoza®, 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 Victoza®, 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 Victoza® 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 Victoza®, tell your doctor about all the medications you take, especially sulfonylurea medicines or insulin, as taking them with Victoza® may affect how each medicine works.  

Also tell your doctor if you are allergic to any of the ingredients in Victoza®; 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 Victoza® will harm your unborn baby or if Victoza® passes into your breast milk.  

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, diarrhea, and resistance to liraglutide (antibody formation).  Nausea is most common when first starting Victoza®, but decreases over time in most people.  Immune system related reactions, including hives, were more common in people treated with Victoza® compared to people treated with other diabetes drugs in medical studies.  

For more information, ask your healthcare provider or pharmacist.

For full prescribing information and Medication Guide, please go to Victoza.com or call 1-877-VICTOZA® (1-877-484-2869)

About Victoza®

Victoza® is the first and only human GLP-1 (7-37) 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 minor 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.  

Victoza® has also been approved by the European Commission in all 27 European Union member states.  As of June 2010, approval has also been granted by the regulatory authorities in Japan, Norway, Mexico, Iceland, Lebanon, Russia, Argentina, India, Brazil, Canada and Switzerland.  Victoza® has already been commercially launched in the U.S., UK, Japan, 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.

SOURCE Novo Nordisk

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