Date: 2012-06-09
Type of information: Presentation of results at a congress
phase:
Announcement: results presented at the 72nd Scientific Sessions of the American Diabetes Association (ADA) in Philadelphia.
Company: Alkermes (USA - Ireland) Amylin Pharmaceuticals (USA)
Product: Bydureon™ (exenatide)
Action
mechanism: Exenatide is a glucagon-like peptide-1 (GLP-1) receptor agonist. Bydureon® is the first and only once-weekly medicine to be approved by the FDA for the treatment of type 2 diabetes. It is a once-weekly formulation of exenatide, the active ingredient in Byetta® (exenatide) injection, which has been available in the U.S. since June 2005 and is used in nearly 80 countries worldwide.
It works with the body to help make its own insulin when needed, providing continuous glycemic control with just one dose per week. Using Alkermes\' proprietary technology for long-acting medications, the biodegradable microspheres in each dose of Bydureon® provide a controlled release of exenatide throughout the week.
Disease: type 2 diabetes
Therapeutic area: Metabolic diseases
Country:
Trial
details: Patients (n=1,719) with type 2 diabetes who received Bydureon™ in seven randomized, comparator-controlled studies were categorized into four quartiles by baseline body weight (Q1 weight 139.7±14.1 pounds, A1C 8.6 percent; Q2 weight 173.1±8.1 pounds, A1C 8.5 percent; Q3 weight 203.5±9.7 pounds, A1C 8.4 percent; Q4 weight 253.4±26.8 pounds, A1C 8.5 percent). Analysis endpoints were taken at 24-30 weeks. Results included improvements in average A1C (-1.5, -1.4, -1.4 and -1.4 percentage points in each quartile, respectively), fasting glucose (-41.2, -33.3, -32.4 and 34.7 mg/dL, respectively), weight (-2.6, -2.8, -2.5 and -2.8 percent, respectively) and pulse pressure (-2.7, -2.5, -2.4 and -1.5 mmHg, respectively).
Latest
news: Amylin Pharmaceuticals and Alkermes have announced results from an analysis of seven randomized clinical studies demonstrating that patients treated with Bydureon™ (exenatide extended-release for injectable suspension), the first and only once-weekly treatment for type 2 diabetes, experienced improvements in A1C, fasting glucose, weight and pulse pressure, regardless of baseline body weight.
In the clinical data analysis, more than 1,700 patients were stratified in quartiles by baseline body weight.
Results showed that A1C reduction and weight loss were comparable across all quartiles (A1C: 1.4-1.5 percentage points; weight: 2.5-2.8 percent). A1C is a measure of average blood sugar over three months.
The most common adverse event overall was hypoglycemia (16.4 percent), which was more prevalent in patients receiving a concomitant sulfonylurea (28.0 percent) than in those who were not (7.5 percent). Other common adverse events were nausea (14.7 percent) and diarrhea (10.9 percent).
