Amylin (AMLN), Alkermes (ALKS) Say BYDUREON Achieved Statistically Significant Glycemic Control Results in Type 2 Diabetes
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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.
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).
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.
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).
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