A long-acting form of Eli Lilly, Amylin Pharmaceuticals and Alkermes’ diabetes drug Byetta (exenatide) has generated positive data in a Phase II study amongst 45 patients with uncontrolled type 2 diabetes.
The long-acting drug, given once-weekly, was well tolerated over a 15 week period and resulted in therapeutic blood levels of Byetta. As a result of this, dose-dependent improvements in glycosylated haemoglobin (HbA1c) – a marker of blood glucose levels – and weight were observed.
Byetta is the first in a new class of drugs for the treatment of type 2 diabetes called incretin mimetics, designed to stimulate the body’s ability to produce insulin in response to elevated levels of blood sugar.
Over the study period, HbA1c improved approximately 2% for subjects receiving the high dose Byetta, compared to placebo. Twelve of the 14 high-dose subjects who entered the study with an HbA1c greater than 7% achieved an HbA1c of 7% or less at 15 weeks, but none of the 14 subjects receiving placebo achieved that target. The American Diabetes Association recommends a target HbA1c of less than 7%.
Furthermore, subjects in the high-dose group saw an average weight reduction of approximately 9 pounds compared to those receiving placebo. Although 20% of the high-dose group experienced mild nausea, Lilly et al say there were reports of either severe gastrointestinal side effects or severe hypoglycaemia.
Byetta was approved as a twice-daily medication by the US Food and Drug Administration in April [[03/05/05d]], and the three companies are using Alkermes’ Medisorb injectable long-acting release drug delivery technology to develop longer-acting formulations.
Diabetes is the fifth leading cause of death by disease in the
USA and costs approximately $132 billion per year in direct and
indirect medical expenses. According to the Centers for Disease Control and Prevention's National Health and Nutrition Examination Survey, approximately 60% of diabetes patients do not achieve target HbA1c levels according to American Diabetes Association guidelines with their current treatment regimen.