Improvements in Systolic Blood Pressure and Triglycerides Also
Observed
Amylin Pharmaceuticals, Inc. (Nasdaq: AMLN), Eli Lilly and Company
(NYSE: LLY), and Alkermes, Inc. (Nasdaq: ALKS) today announced
long-term, interim results from the DURATION-1 study that showed
sustained glucose control with weight loss, as well as improvements in
systolic blood pressure and triglycerides, through two years of
treatment with exenatide once weekly, an investigational therapy for
type 2 diabetes. These findings were presented at the 69th
Annual Scientific Sessions of the American Diabetes Association (ADA) in
New Orleans. A New Drug Application (NDA) for exenatide once weekly was
recently submitted to the U.S. Food and Drug Administration.
In the controlled portion of the open-label study, patients received
exenatide once weekly or BYETTA® (exenatide) injection for 30
weeks, followed by 74 weeks of treatment with exenatide once weekly for
all patients during an open-ended assessment period. Significant
reductions in A1C of 1.7 percent and fasting plasma glucose (FPG) of 40
mg/dL were maintained after two years of treatment. Sixty-five percent
of patients achieved an A1C of 7 percent or less. (A1C of less than 7
percent is the target for good glucose control as recommended by the
ADA.) Body weight was significantly reduced, with patients losing an
average of 5.8 pounds. Serum lipid profiles were significantly improved,
and there was a significant reduction in systolic blood pressure (SBP).
“These two-year DURATION-1 data showed that maintenance of steady state
concentrations of exenatide may result in sustained improvements in
glycemic control, with potential weight loss,” said Orville G.
Kolterman, M.D., senior vice president of research and development at
Amylin. “In DURATION-1, exenatide once weekly has been shown to provide
superior glycemic control, with weight loss, compared to BYETTA. If
approved, this therapy could fill an important unmet need for treating
patients with type 2 diabetes with just one dose per week.”
Study Design and Findings
The study enrolled 295 patients, with nearly 75 percent completing the
two years of treatment. Baseline characteristics for these patients
were: A1C 8.2±1.0%, FPG 168±43 mg/dL, body weight 223±41 pounds, BMI
34.8±4.8 kg/m2, diabetes duration 7.1±5.3 years. Significant
improvements in both A1C [-1.7±0.1%] and FPG [-40±3 mg/dL] were
maintained after two years of treatment, body weight was significantly
reduced [-5.8±1.2 pounds], serum lipid profiles were significantly
improved [total cholesterol -8.6±2.8 mg/dL; LDL cholesterol -4.5±2.2
mg/dL; triglycerides -15±3 percent], and there was a significant
reduction in SBP [-3.0±1.0 mmHg for all participants and -9.4±1.5 mmHg
for those with abnormal baselines].
Safety Profile
Nausea was the most common event during the 30-week treatment period and
decreased over time, occurring in 12 percent of patients during the
74-week assessment period when all patients were receiving exenatide
once weekly. No severe hypoglycemia was observed. The safety profile of
patients treated in this study was consistent with the previously
reported profiles of BYETTA and exenatide once weekly.
About Diabetes
Diabetes affects more than 23 million people in the United States and an
estimated 246 million adults worldwide.(i,ii) Approximately 90-95
percent of those affected have type 2 diabetes.
