Year of weekly exenatide beneficial in type 2 diabetes

In patients with type 2 diabetes, a once-weekly formulation of exenatide (Byetta, Amylin Pharmaceuticals) is associated with sustained improvements in glycemic control and body weight over 52 weeks, and patients who switch from a twice-daily to a once-weekly regimen have further improvements in hemoglobin A1C and fasting plasma glucose, according to research published in the June issue of Diabetes Care, as reported in HealthDay News.

John B. Buse, MD, PhD, of the University of North Carolina School of Medicine in Chapel Hill and colleagues analyzed data from 258 patients in the 30-week DURATION-1 exenatide study who entered a 22-week assessment phase. Roughly one-half continued taking the drug once weekly, and the rest switched from the twice-daily formulation to the once-weekly injection.

The researchers found that those continuing exenatide once weekly maintained A1C improvements through the 52 weeks (least squares mean – 2.0%). Those who switched to exenatide once weekly from twice daily had further improvements in A1C, and at 52 weeks both groups had the same A1C reduction and mean A1C (6.6%). In both groups, fasting plasma glucose was reduced by more than 40 mg/dL and body weight by more than 4 kg at 52 weeks. Nausea was less common in this period, and the researchers noted no major hypoglycemia.

The transition from exenatide twice daily to exenatide once weekly was made without additional safety and tolerability concerns, according to the study. The clinical benefits of exenatide once weekly were maintained and resulted in a mean A1C of 6.6% after 52 weeks of treatment.

“The switch from the current twice-daily formulation of exenatide to the once-weekly formulation currently under review at FDA was well tolerated and associated with further improvements in blood sugar control,” Dr. Buse told Formulary. “Furthermore, this is the first study to report on longer-term safety and tolerability out to 1 year of the long-acting formulation.”

Dr Buse said the promise of long-acting GLP-1-based therapies to improve the lives of patients with diabetes is substantial. “Outcome studies will be required to prove these hopes,” he said.

Amylin and Eli Lilly sponsored the study, and several authors disclosed financial relationships with these or other pharmaceutical companies.