Amylin, Alkermes announce results from BYDUREON clinical study on type 2 diabetes
Published on June 11, 2012 at 1:25 AM
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
"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).
Amylin Pharmaceuticals, Inc.