Date: 2012-06-09
Type of information: Publication of results in a medical journal
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: UK, Ireland
Trial
details: This multicenter, open-label, parallel-arm study conducted in the United Kingdom and Ireland compared the efficacy and safety of Bydureon™ with titrated insulin detemir in patients with type 2 diabetes inadequately controlled with metformin with or without a sulfonylurea.
Patients were randomized to add-on therapy with Bydureon™ (n=111) or insulin detemir (n=105) for 26 weeks. Insulin detemir was titrated to target fasting plasma glucose according to manufacturer labeling and a treat-to-target titration schedule. The primary endpoint was analyzed by means of logistic regression including factors for treatment, use of sulfonylurea and baseline A1C and weight.
Secondary outcomes included glycemic control measures, cardiovascular markers and safety and tolerability.
Latest
news: Amylin Pharmaceuticals and Alkermes have announced clinical study results which showed that a significantly greater proportion of patients treated with Bydureon™ (exenatide extended-release for injectable suspension), the first and only once-weekly treatment for type 2 diabetes, achieved target glucose levels and weight loss compared to those treated with Levemir® (insulin detemir). In the study, 44.1 percent of patients receiving Bydureon™, compared with 11.4 percent of those treated with insulin detemir, met the primary composite endpoint of A1C less than or equal to 7 percent and weight loss greater than or equal to 2.2 pounds (P less than 0.0001) at 26 weeks. Treatment with Bydureon™ also resulted in greater improvement in A1C (-1.3 percentage points) than insulin detemir (-0.88 percentage points). A1C is a measure of average blood sugar over three months. Patients receiving Bydureon™ lost an average of 5.9 pounds, while those receiving insulin detemir gained an average of 1.8 pounds, resulting in a treatment difference of 7.7 pounds.
"In this study, treatment with Bydureon™ resulted in a significantly greater proportion of patients achieving target glucose levels compared to insulin detemir and was associated with weight loss and a lower risk of hypoglycemia,\" said Melanie J. Davies, M.D., FRCP, professor of diabetes medicine at the University of Leicester, United Kingdom and honorary consultant at University Hospitals of Leicester. \"In everyday clinical practice, glycemic control, weight management and hypoglycemia risk are all critical factors in managing type 2 diabetes, and these data suggest that Bydureon™ may be a good alternative to insulin detemir in type 2 diabetes patients who are not achieving adequate glycemic control on metformin with or without a sulfonylurea.\"
There were no events of major hypoglycemia in either group. Gastrointestinal-related and injection-site-related adverse events occurred more frequently with Bydureon™ than with insulin detemir.
