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Once Weekly Byetta Shows A 1.9% Drop in A1c

Posted: Wednesday, November 07, 2007

Once-Weekly Exenatide showed statistical superiority in glucose control compared to BYETTA in head-to-head study.

The once-weekly version of Eli Lilly & Co.'s diabetes drug Byetta controls blood sugar better than the daily form now sold, suggesting the new product may become the most convenient therapy for the disease.

Lilly and Amylin announced the positive results from a 30-week comparator study of once-weekly exenatide long-acting release (LAR) injection and BYETTA(R) (exenatide) injection taken twice daily in patients with type 2 diabetes. Once-weekly exenatide, an investigational drug, showed a statistically significant 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 7 percent or less. A1C of less than 7 percent is the target for good glucose control as recommended by the American Diabetes Association.
After 30 weeks of treatment, both once-weekly exenatide and BYETTA treatment resulted in an average weight loss of approximately eight pounds. Nearly 90 percent of subjects in both groups completed the study, which enrolled patients not achieving adequate glucose control with either diet and exercise or with use of oral glucose-lowering agents. The companies anticipate a regulatory submission to the FDA by the end of the first half of 2009.

There was no major or severe hypoglycemia regardless of background therapy. As expected based on prior BYETTA studies, minor hypoglycemia with once-weekly exenatide use was limited to subjects using background sulfonylurea therapy. Once-weekly exenatide was associated with approximately 30 percent less nausea than BYETTA. Approximately one out of five subjects receiving once-weekly exenatide reported treatment-related nausea during the 30-week study. In both groups nausea was predominantly mild and transient. The antibody profile of subjects treated in this study was consistent with the previously reported profiles of BYETTA and once-weekly exenatide.

Once-weekly exenatide uses a proprietary technology for long-acting medications developed by Alkermes. The technology encapsulates active medication into polymer-based microspheres that are injected into the body where they degrade slowly, gradually releasing the drug at a carefully controlled rate.

Study Design: The 30-week, open-label, noninferiority study included 295 subjects with type 2 diabetes who were not achieving adequate glucose control using diet and exercise with or without the use of one or more oral antidiabetic agents. Subjects were randomized to receive subcutaneous injections of either once-weekly exenatide 2.0 milligrams or BYETTA taken twice daily as outlined in the approved label. Subjects in both groups who completed the randomized portion of the study continued in the open-ended portion of the study receiving once-weekly exenatide.
Full study results will be included in future scientific publications.

The plans are to file for the new drug application by the end of June 2009, but it might be sooner.

Byetta was introduced In April 2005 and has been used by more than 700,000 patients since its introduction. BYETTA is indicated for use twice a day in adults with type 2 diabetes who are unsuccessful at controlling their blood sugar levels using common oral diabetes medications.

Source: Diabetes In Control: Announced at the Financial webcast Oct 30, 2007