Novo Nordisk presented results demonstrating that once-daily Victoza® (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® 1.8 mg and 55% treated with Victoza® 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® 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® 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® 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® 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® is not a weight-loss product.
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® (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 LEADTM (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® is an injectable prescription medicine that may improve blood sugar (glucose) in adults with type 2 diabetes when used along with diet and exercise.
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