Amylin Pharmaceuticals, Inc. (Nasdaq: AMLN) and Alkermes plc (Nasdaq: ALKS) today announced results from the long-term extension of the DURATION-1 study, which showed that BYDUREON™ (exenatide extended-release for injectable suspension), the first and only once-weekly treatment for type 2 diabetes, was associated with clinically significant and sustained improvements in glycemic control during four years of treatment in adults with type 2 diabetes.
In the study, being presented at the 72nd Scientific Sessions of the American Diabetes Association in Philadelphia, patients completing four years of BYDUREON treatment experienced clinically significant improvements in A1C (1.7 percentage points) and fasting plasma glucose (-37 mg/dL) from baseline. A1C is a measure of average blood sugar over three months. Although BYDUREON is not indicated for weight loss, patients treated with BYDUREON also lost an average of 5.5 pounds from baseline.
“In this study, patients treated with just one dose per week of BYDUREON for four years experienced sustained improvement in glycemic control and showed reductions in certain cardiometabolic measures. The tolerability of BYDUREON also improved over time with long-term treatment,” said Christian Weyer, M.D., senior vice president, research and development, Amylin Pharmaceuticals. “The durability of treatment effectiveness and tolerability of BYDUREON are critically important in managing the chronic and progressive condition of type 2 diabetes.”
Patients treated with BYDUREON also experienced statistically significant reductions in certain cardiovascular risk markers, including systolic blood pressure (-1.6 mmHg), total cholesterol (-10.9 mg/dL), LDL cholesterol (-8.0 mg/dL) and triglycerides (-13 percent). No unexpected safety findings were observed with long-term BYDUREON therapy, and incidence of mild nausea, the most common adverse event during the controlled portion of the study, decreased over time (27 percent weeks 1-30; 1.6 percent weeks 180-212).Study Details DURATION-1 compared the efficacy of once-weekly BYDUREON against twice-daily BYETTA ® (exenatide) injection in a 30-week, randomized, open-label study. Following the controlled portion of the study, 258 of the 295 intent-to-treat patients (87 percent) entered the extension study. A total of 68 percent of patients (n=176) completed four years of treatment, 55 percent of whom achieved the ADA-recommended A1C target of less than 7 percent. Primary endpoints were change from baseline to year four in A1C, and long-term safety and tolerability. About BYDUREON™ (exenatide extended-release for injectable suspension) BYDUREON is the first and only once-weekly medicine to be approved by the U.S. Food and Drug Administration (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. BYDUREON 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. BYDUREON was approved in the U.S. in January 2012 and in Europe in June 2011. BYDUREON is an injectable prescription medicine that may improve blood sugar (glucose) in adults with type 2 diabetes mellitus, and should be used along with diet and exercise. BYDUREON is not recommended as the first medication to treat diabetes.