Once-weekly diabetes treatment looking good
compared to its twice-daily counterpart.
Amylin Pharmaceuticals, Eli Lilly and Alkermes have developed a long-acting release formulation of exenatide, which is currently marketed as Byetta, a twice-daily injection. The results from a 30-week comparator study of the two products showed a "statistically significant improvement" in the A1C test, which gives a picture of average blood glucose control over a two to three month period to indicate how well diabetes treatment is working. According to the companies, the once-weekly formulation showed an improvement in A1C of approximately 1.9 percentage points from baseline, compared to an improvement of approximately 1.5 percentage points for Byetta. Approximately three out of four subjects treated with once-weekly exenatide achieved an A1C of seven per cent or less. A1C of less than seven per cent is the target for good glucose control as recommended by the American Diabetes Association. During the study, both treatments showed an average weight loss in the subjects of approximately eight pounds. "Together with our collaboration partners Lilly and Alkermes, we are pleased that use of once-weekly exenatide met the primary endpoint with a greater reduction in A1C than Byetta and with significant weight loss, both key measures of success in the management of Type II diabetes," Amylin clinical and regulatory affairs senior vice president Orville Kolterman said. "These data confirm the benefits of Byetta as an important treatment option and suggest that, if approved, once-weekly exenatide has the potential to help patients improve their diabetes management." The once-weekly formulation uses an Alkermes technology for long-acting medications whereby the medication is encapsulated into polymer-based microspheres that degrade slowly in the body, gradually releasing the drug at a carefully controlled rate. Exenatide is an incretin mimetic which has the ability to exhibit many of the same effects as the human incretin hormone glucagon-like peptide-1 (GLP-1), such as improving blood sugar after food intake. Byetta is the first in this class of drugs to be approved for treatment of Type II diabetes. It is for use by people who are unsuccessful at controlling their blood sugar levels using common oral diabetes medicines. The companies expect regulatory submission to the US Food and Drug Administration by the end of the first half of 2009.