Novo Nordisk (NYSE: NVO) presented results recently demonstrating that once-daily Victoza(R) (liraglutide [rDNA] injection) achieved significantly greater improvements in blood sugar control compared to placebo among African-American patients with type 2 diabetes. The meta-analysis of phase 3 data from the Liraglutide Effect and Action in Diabetes (LEAD) trials were presented at the 2010 National Medical Association Annual Convention & Scientific Assembly.
The findings showed of the 187 African-American patients in the trials, 78% treated with Victoza(R) 1.8 mg and 55% treated with Victoza(R) 1.2 mg once-daily reached the American Diabetes Association’s (ADA) blood sugar target of < 7%, versus 19% of patients treated with placebo after 26 weeks. African-Americans are 1.6 times more likely to have diabetes than non-Hispanic whites, and according to the ADA, 25% of African Americans between the ages of 65 and 74 have diabetes.
“This analysis affirms that Victoza(R) is a safe and effective treatment for African-Americans with type 2 diabetes, and may be a good option for those patients struggling with blood sugar control,” said Dr. Anthony Cannon, Chief of Endocrinology, Robert Wood Johnson University Hospital, New Jersey and study investigator. “African-Americans are among the most affected by diabetes, so it’s important that we examine the safety and efficacy of diabetes treatments in this patient population.”
In addition to providing significantly better blood sugar control, Victoza(R) produced greater reductions in body weight compared to the placebo group. After 26 weeks, those in the 1.8 mg and 1.2 mg Victoza(R) groups lost an average of 5.06 lbs (2.30 kg) and 1.10 lbs (0.5 kg) respectively, compared to 0.88 lbs (0.4 kg) for the placebo group.
“African-Americans with type 2 diabetes, are 1.4 more times as likely to be obese as non-Hispanic whites,” said Dr. Cannon. “The added benefit of weight loss associated with Victoza(R) may be an important factor in selecting treatment for African-Americans with type 2 diabetes who struggle with weight issues. Even modest weight loss can make a significant difference in the management of their diabetes.”
Victoza(R) is not a weight-loss product.
Study Results
| African-American/Black population | Victoza(R)1.2 mg N=76 | Victoza(R)1.8mg N=84 | Placebo N=27 |
| Baseline A1c, % | 8.5 | 8.5 | 8.7 |
| Change A1c, % | -1.3 | -1.6 | -0.3 |
| A1c < 7% (%) | 55 | 78 | 19 |
| Baseline BMI | 34.0 | 33.7 | 33.2 |
| Change weight, kg | -0.5 | -2.3 | -0.4 |
| Change FPG, mg/dL | -39.0 | -55.0 | 4.8 |
About the Study
The results are from a meta-analysis of the six phase 3 Liraglutide Effect and Action in Diabetes (LEAD) trials. The pooled analysis compared the efficacy and safety of two doses of once-daily Victoza(R) (1.2 mg and 1.8 mg) to placebo over 26 weeks in 187 patients with an average age of 53.1 years, who had been living with type 2 diabetes for an average of 7.2 years.
The most common gastrointestinal-related adverse events were nausea, which was transient. Low rates of minor hypoglycemia were reported.
About the LEAD Program
The LEAD(TM) (Liraglutide Effect and Action in Diabetes) program comprised five randomized, controlled, double-blinded studies plus one open-label head-to-head study against exenatide and involved more than 4,400 patients with type 2 diabetes in more than 40 countries.
Indications and Usage
Victoza(R) 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(R) is not recommended as the first medication to treat diabetes. Victoza(R) is not insulin and has not been studied in combination with insulin. Victoza(R) is not for people with type 1 diabetes or people with diabetic ketoacidosis. It is not known if Victoza(R) is safe and effective in children. Victoza(R) is not recommended for use in children.
Important Safety Information
In animal studies, the medicine in Victoza(R) caused thyroid tumors — including thyroid cancer — in some rats and mice. It is not known whether Victoza(R) 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(R) 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(R), 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(R), 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(R) 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(R), tell your doctor about all the medications you take, especially sulfonylurea medicines or insulin, as taking them with Victoza(R) may affect how each medicine works.
Also tell your doctor if you are allergic to any of the ingredients in Victoza(R); 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(R) will harm your unborn baby or if Victoza(R) passes into your breast milk.
Your risk for getting hypoglycemia, or low blood sugar, is higher if you take Victoza(R) 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(R).
The most common side effects with Victoza(R) include headache, nausea, diarrhea, and resistance to liraglutide (antibody formation). Nausea is most common when first starting Victoza(R), but decreases over time in most people. Immune system related reactions, including hives, were more common in people treated with Victoza(R) 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 http://www.victoza.com/ or call 1-877-VICTOZA(R) (1-877-484-2869)
About Victoza(R)
Victoza(R) is the first and only human GLP-1 analog that is 97% similar to endogenous human GLP-1. Like natural GLP-1, Victoza(R) (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(R) is associated with a low rate of minor hypoglycemia. The mechanism of blood sugar lowering also involves a delay in gastric emptying.
Victoza(R) 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(R) 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(R) 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.
Source: Novo Nordisk