Long-acting exenatide effective

An experimental, once-a-week version of exenatide (Byetta) provided better glycemic control and less nausea in type 2 diabetics  than the current twice-daily regimen in a recent clinical trial.

The study has major implications for patient compliance, says co-author John B. Buse, MD, director of the Diabetes Care Center at the University of North Carolina at Chapel Hill.

“I have trouble remembering to take medications on time,” he confides. “If approved, once-weekly exenatide will provide an extremely forgiving way to take diabetes medication.”

The open-label, randomized trial evenly divided 259 patients who injected themselves with either
2 mg exenatide once a week or 10 µg twice a day. Mean hemoglobin A1c (HbA1c) among all participants was 8.3% at baseline (Lancet. 2008;372:1240-1250).

After 30 weeks, both groups had significant reductions in HbA1c, but patients in the weekly arm enjoyed a sharper decline. They saw their HbA1c levels fall to a mean of 6.4 (-1.9 points), while twice-daily patients experienced a drop to only 6.8 (-1.5 points).

In addition, more patients taking the once-weekly formulation achieved the target HbA1c of <7.0 (77% weekly vs. 61% twice-daily). That pattern held, though less dramatically, for those achieving levels <6.5 (49% vs. 42%) and <6.0 (25% vs. 18%). Patients who were more severely diabetic at baseline also did much better with the long-acting formulation. Among patients with HbA1c >9 at baseline, significantly more (65% vs. 35%) achieved HbA1c < after 30 weeks.

Patients in both groups reported mild nausea, but no one in the weekly arm described his or her discomfort as severe.

A few days after The Lancet posted this study online, Dr. Buse presented updated data to the European Association for the Study of Diabetes. After 52 weeks, patients on the long-acting regimen are maintaining HbA1c reductions of 1.5-2 points, he reported.

The project was funded by Amylin Pharmaceuticals and Eli Lilly and Company, which manufacture the drugs. The companies were involved in the study design, protocol development, and the collection and analysis of data, the researchers disclosed.
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