New Data Shows Victoza Helped Reduce Blood Sugar When Patients With Type 2 Diabetes Switched From Sitagliptin or Exenatide

Another study shows benefits of adding Levemir® insulin therapy to Victoza®

SAN DIEGO, June 25, 2011 /PRNewswire/ -- Novo Nordisk will present data from two extension studies at the 71st Annual Scientific Sessions of the American Diabetes Association (ADA) which show that Victoza® (liraglutide [rDNA origin] injection), taken once-daily, in combination with metformin and/or sulfonylurea, helped patients achieve blood sugar control after switching from other commonly used type 2 diabetes therapies. Although not a weight loss product, the data also demonstrate that patients experienced weight loss when switched from sitagliptin to Victoza®.

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Novo Nordisk will also present data that demonstrates the addition of Levemir® (insulin detemir [rDNA origin] injection) to Victoza® and metformin helped patients reach and maintain blood sugar targets, with a low frequency of hypoglycemia and maintained weight loss.

"The results of this study are encouraging. Not only did Victoza® treatment alone help more than 60% of patients achieve the ADA target for blood sugar control, but also the addition of Levemir® helped many of the remaining patients achieve the ADA target without the increases in hypoglycemia and body weight normally associated with insulin therapy," said Mads Krogsgaard Thomsen, Executive Vice President and Chief Science Officer, Novo Nordisk.

Key findings from the studies include:

Switching from exenatide to Victoza® (Poster 1117-P)

* The majority of patients switched from exenatide to Victoza® experienced further reductions in HbA1C (0.3 – 0.8%)
* In the study, 32% of patients who failed to reach target (HbA1C <7%) with exenatide subsequently reached target with Victoza® with mean 0.8% further reductions in HbA1C


Switching from the DPP-4 inhibitor sitagliptin to Victoza® (Poster 1119-P)

* Patients switched from sitagliptin to Victoza® 1.2 mg and 1.8 mg experienced further reductions in HbA1C (0.2% and 0.5%, respectively)
* More patients treated with Victoza® 1.2 mg and 1.8 mg after switching from sitagliptin (49.2 and 50 vs. 29.5%, respectively) reached the ADA target for blood sugar control (HbA1C <7%)
* Although Victoza® is not a weight loss product, patients switched from sitagliptin to Victoza® 1.2 mg and 1.8 mg also experienced significant reductions in body weight (1.6 kg [3.5 lbs] and 2.5 kg [5.5 lbs], respectively)


Adding Levemir® to Victoza® (Oral Presentation 276-OR)

* After completing 12 weeks of treatment with Victoza® and metformin, 61% of patients reached the ADA target for blood sugar control (HbA1C <7%) with mean decreases in HbA1C of 1.3% and body weight of 4.4 kg (9.7 lbs)
* After the additional 26 weeks, patients randomized to add on Levemir® to Victoza® and metformin had further HbA1C reductions of 0.5%, while HbA1C remained stable in the Victoza® and metformin group
o Furthermore, 43% of patients in the Victoza®, metformin and Levemir® group reached the ADA target for blood sugar control (HbA1C <7%) at 26 weeks vs. an additional 17% in the Victoza® and metformin group
* Patients maintained their weight after Levemir® was added


About the Studies

Both switch trials were extensions of randomized, open-label studies that compared the efficacy and safety of Victoza®, 1.2 mg and/or 1.8 mg, taken once-daily, to exenatide 10 micrograms, twice a day (n=389) or sitagliptin 100mg (n=135), all in combination with metformin and/or sulfonylurea.

All patients in the extension arms were treated with once-daily Victoza® 1.2 mg or 1.8 mg and metformin and/or sulfonylurea.

To evaluate the safety and efficacy of adding Levemir® to treatment with Victoza® 1.8 mg and metformin, a 38-week, randomized, open-label study was conducted (n=821). In the initial 12 weeks, patients were treated with Victoza® and metformin. During the following 26 weeks, patients achieving HbA1C <7% remained in an observational arm while the remaining patients were randomized to Victoza®, metformin and Levemir® or Victoza® and metformin.

In all studies, for patients treated with Victoza®, the most common gastrointestinal-related adverse events were nausea, which was transient, or short in duration. Low rates of minor hypoglycemia were also reported.

About Victoza®

Victoza® is the first and only human glucagon-like peptide-1 (GLP-1) analog that is 97% similar to endogenous human GLP-1. Like natural GLP-1, Victoza® 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.

As of June 2011, Victoza® has been commercially launched in more than 30 countries globally including the US, Canada, Japan, UK, Germany, France, Italy, Denmark, Hungary, Russia, India, Brazil, Mexico, Argentina, the GULF and Malaysia as well as a number of other countries, and will be available in other markets throughout 2011 and 2012.

Indications and Usage for Victoza® (liraglutide [rDNA origin] injection)

Victoza® is an injectable prescription medicine that may improve blood sugar (glucose) in adults with type 2 diabetes when used along with diet and exercise.

Victoza® (liraglutide [rDNA origin] injection) 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 for Victoza®

In animal studies, 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 symptoms 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 medicines 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®.

Victoza® may cause nausea, vomiting, or diarrhea leading to dehydration, which may cause kidney failure. This can happen in people who have never had kidney problems before. Drinking plenty of fluids may reduce your chance of dehydration.

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. 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.

Indications and Usage for Levemir® (insulin detemir [rDNA origin] injection)

Levemir® is a man-made long-acting insulin that is used to control high blood sugar in adults and children with diabetes mellitus.

Important Safety Information for Levemir®

Do not take Levemir® (insulin detemir [rDNA origin] injection) if your blood sugar is too low (hypoglycemia) or if you are allergic to anything in Levemir®. If you take too much Levemir® your blood sugar may fall too low.

Check your blood sugar levels. Ask your health care provider what your blood sugars should be and when you should check your blood sugar levels. Alcohol, including beer and wine, may affect your blood sugar when you take Levemir®.

Do not change the type of insulin you use unless told to do so by your health care provider. The amount of insulin you take as well as the best time for you to take your insulin may need to change if you take a different type of insulin.

Never mix Levemir® with other insulin products or use in an insulin pump.

Needles and Levemir® FlexPen® must not be shared.

Tell your health care provider about all medicines you take and all of your medical conditions, including if you are pregnant or breastfeeding. Your Levemir® dose may change if you take other medicines.

The most common side effect of Levemir® is low blood sugar (hypoglycemia). Other possible side effects include reactions at the injection site (like redness, swelling and itching), and allergic reactions. Get medical help right away if you experience signs of serious allergic reaction such as body rash, trouble with your breathing, fast heartbeat, or sweating. Ask your doctor or pharmacist for further information.

For full Victoza® Prescribing Information, please see http://www.novo-pi.com/victoza.pdf or call 1-877-VICTOZA® (1-877-484-2869). For full prescribing information for Levemir®, please see: http://www.novo-pi.com/levemir.pdf.

Headquartered in Denmark, Novo Nordisk is a global healthcare company with 88 years of innovation and leadership in diabetes care. The company also has leading positions within hemophilia care, growth hormone therapy and hormone replacement therapy. For more information, visit www.novonordisk-us.com .

©2011 Novo Nordisk 0511-00002594-1 June 2011

SOURCE Novo Nordisk

CONTACT: Media, Europe: Katrine Sperling, +45-4442-6718, krsp@novonordisk.com; Media, North America: Ambre Morley, +1-609-987-5898, abmo@novonordisk.com, or Havilah Clarke, +1-609-423-3057, hvck@novonordisk.com; Investors: Klaus Bulow Davidsen, +45-4442-3176, klda@novonordisk.com, or Kasper Roseeuw Poulsen, +45-4442-4471, krop@novonordisk.com, or Hans Rommer, +1-609-919-7937, hrmm@novonordisk.com

Web Site: http://www.novonordisk-us.com

Posted: June 2011

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