Victoza® Meta-Analysis Shows Greater Blood Sugar Control at all Baseline A1C Levels When Compared to Other Therapies

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Apr 14, 2011, 01:00 ET

SAN DIEGO, April 14, 2011 /PRNewswire/ -- Novo Nordisk presented data today that showed regardless of baseline A1C, once-daily Victoza® (liraglutide [rDNA origin] injection) 1.8 mg consistently helped more patients achieve blood sugar control than some other commonly used type 2 diabetes therapies. The data were presented at the 20th Annual Meeting and Clinical Congress of the American Association of Clinical Endocrinologists (AACE).

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Key findings from the study include:

Overall A1C reductions achieved with Victoza® were greater than reductions observed with comparator therapies across all baseline A1C categories.
The number of patients achieving the AACE target A1C of less than or equal to 6.5% demonstrates the benefit of Victoza® across all baseline A1C categories.
A greater proportion of patients achieved the AACE A1C target with Victoza® than with comparator therapies in the lower range of baseline A1C categories.

"What is so encouraging about these data is that Victoza®, at all baseline A1C levels, helped type 2 diabetes patients achieve improved blood sugar control," said Dr. Robert Henry, President, Medicine & Science of the American Diabetes Association and Professor of Medicine, Department of Medicine, Division of Endocrinology and Metabolism at the University of California, San Diego. "This is particularly promising since we know many type 2 diabetes patients continue to struggle with blood sugar control."

Significantly more patients (63%) in the baseline less than or equal to 7.5% category, treated with Victoza®, achieved the AACE recommended A1C target of less than or equal to 6.5% as compared to other anti-diabetic therapies (20-49%).

About the study

This study is a meta-analysis (combined results from several studies) of seven studies on Victoza® (liraglutide [rDNA origin] injection), including the six phase III LEAD (Liraglutide Effect and Action in Diabetes) studies, performed to determine the mean changes in A1C from baseline to week 26. Victoza® (liraglutide [rDNA origin] injection) 1.8 mg was compared with exenatide, insulin glargine, glimepiride, rosiglitazone, and sitagliptin. Baseline A1C categories included less than or equal to 7.5%, >7.5-8.0%, >8.0-8.5%, >8.5-9.0%, >9.0%. Logistic regression was also used to compare the percentage of patients achieving the AACE target A1C of less than or equal to 6.5%.

The study determined that all diabetes therapies improved blood sugar control across all baseline A1C categories, with greater reductions at higher baseline A1C levels as compared to placebo (added to background therapy). The greatest reductions were observed in the Victoza® group and ranged from 0.7% in the less than or equal to 7.5% category to 1.8% in the >9.0% category.

Victoza® reductions were followed by insulin glargine (0.3-1.5%) and exenatide (0.4-1.3%). Patients taking sitagliptin experienced no reduction in the less than or equal to 7.5% category to 1.1% in the >9.0% category. Patients taking sulfonylureas had a 0.4%-1.4% reduction. Patients treated with thiazolidinediones (TZDs) had the narrowest margin of reduction, from 0.4% in the less than or equal to 7.5% category to 0.8% in the >9.0% category.

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 April 2011, Victoza® has been approved by the European Commission in all 27 European Union member states, and by regulatory authorities in China, 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 2011.

Indications and Usage

Victoza® (liraglutide [rDNA origin] injection) 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

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®.

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® (liraglutide [rDNA origin] injection) compared to people treated with other diabetes drugs in medical studies.

For full Prescribing Information and Medication Guide, please see Victoza.com or call 1-877-VICTOZA® (1-877-484-2869)

Headquartered in Denmark, Novo Nordisk is a global healthcare company with 87 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.

SOURCE Novo Nordisk