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Healio
July 29, 2009
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Liraglutide improved HbA1c, weight in black patients with diabetes

114th National Medical Association Annual Convention and Scientific Assembly

Monotherapy with once-daily liraglutide — an investigational glucagon-like peptide-1 agonist — was associated with significant, sustained reductions in blood glucose and weight in black patients with type 2 diabetes compared with glimepiride, according to a post-hoc analysis of the LEAD-3 study.

The randomized, controlled, double-blind study included 94 patients with type 2 diabetes enrolled in the LEAD-3 monotherapy study. All patients self-identified as black.

“We know that blacks are disproportionately affected by type 2 diabetes, hypertension, dyslipidemia and cardiovascular disease, yet many clinical trials have not looked at this population specifically,” Mansur Shomali, MD, associate director of the Diabetes and Endocrine Center at Union Memorial Hospital in Baltimore, told Endocrine Today.

Researchers conducted the post-hoc analysis “based on an increased need to know how drugs like liraglutide specifically work in different populations and based on the need for inclusion of minority populations,” Shomali said.

The trial compared the safety and efficacy of two doses of daily liraglutide (Victoza, Novo Nordisk) with glimepiride in patients with diabetes treated with diet and exercise and not more than two months of prior treatment with low-dose oral antidiabetes agents.

The data were presented this week at the 114th National Medical Association Annual Convention and Scientific Assembly in Las Vegas.

Safety, efficacy

After 52 weeks, 64% of black patients assigned to daily liraglutide 1.8 mg reached and maintained the blood glucose target of <7% and 29% of patients assigned 1.2 mg achieved the goal vs. 11% assigned glimepiride 8 mg.

In addition to its effects on blood glucose, liraglutide was also associated with weight loss after 52 weeks. Patients assigned to the 1.8-mg dose experienced a 6.57 lb decrease in mean body weight and the 1.2-mg dose was associated with a loss of 1.54 lb. By comparison, the glimepiride group experienced a slight decrease in weight of 1.10 lb.

Minor hypoglycemic events were less common with the 1.2-mg dose and significantly less common with the 1.8-mg dose compared with glimepiride. Other common adverse events were gastrointestinal-related, such as mild, transient nausea, diarrhea and vomiting, and some patients reported flu-like symptoms.

"Liragutide has specific advantages for patients who are obese, have type 2 diabetes and a high risk of CVD," Shomali said. "Because of its well tolerability, ease of use and longevity of effect in this 52-week study, it has the potential to be a fabulous agent for the treatement of type 2 diabetes in high-risk individuals."

LEAD-3 is one of five studies that make up the phase 3 program for liraglutide. The LEAD program is comprised of five randomized, controlled, double-blinded studies plus one open-label, head-to-head study against exenatide (Byetta, Amylin). The studies have included nearly 6,500 patients with type 2 diabetes in more than 40 countries.

In June, data presented at the American Diabetes Association’s 69th Scientific Sessions demonstrated similar benefits of liraglutide in patients with diabetes whose race/ethnicity was not defined.

Novo Nordisk submitted a New Drug Application to the FDA in May 2008. On July 3, the company announced that the European Commission granted marketing authorization for liraglutide for the treatment of type 2 diabetes. – by Katie Kalvaitis

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