Monotherapy BYETTA(R) Showed Significant Improvement in Glucose Control and Weight Loss in Adults with Type 2 Diabetes
- FDA Submission Planned in First Half of 2008 -
SAN DIEGO and INDIANAPOLIS, Dec. 6 /PRNewswire-FirstCall/ -- Amylin Pharmaceuticals, Inc. (Nasdaq: AMLN) and Eli Lilly and Company (NYSE: LLY) today announced study results from a 24-week study of monotherapy, or stand-alone, BYETTA (exenatide) injection taken twice daily in drug-naive patients with type 2 diabetes. Study participants taking 5 mcg or 10 mcg of monotherapy BYETTA twice daily showed significant reductions in A1C (a measure of average blood sugar over 3 months) by 0.7 percentage points and 0.9 percentage points, respectively, from an average baseline A1C ranging from 7.8 to 7.9 percent. In addition, approximately 60 percent of study participants on either 5 mcg or 10 mcg of monotherapy BYETTA at the conclusion of the study had an A1C of 7 percent or less, a common target for good glucose control. The companies plan a regulatory submission to the U.S. Food and Drug Administration (FDA) in the first half of 2008.
In this 24-week, randomized, placebo-controlled study, 232 drug-naive people with type 2 diabetes were treated with monotherapy BYETTA or placebo. More than 85 percent of study participants in the 5 mcg and 10 mcg arms completed the study. Weight loss from baseline was significant and similar to that observed in previous BYETTA studies.
"The American Diabetes Association's (ADA) clinical guidelines for the treatment of patients with type 2 diabetes are to achieve target glucose control, as well as weight loss in overweight or obese patients," said James Malone, M.D., Global Medical Director, Eli Lilly and Company. "These data are robust and are consistent with data from other trials that support the use of BYETTA before starter insulin. If approved for monotherapy, BYETTA may provide an additional treatment option for physicians to consider earlier in the continuum of care."
There was a low incidence of nausea reported in both treatment arms of the study of approximately 3 and 13 percent in the 5 mcg and 10 mcg arms, respectively. There were no instances of severe hypoglycemia in this study. Overall hypoglycemia observed was similar to that seen in studies where BYETTA was used in conjunction with metformin only.
BYETTA -- the first and only FDA-approved incretin mimetic -- was approved in April 2005 and has been used by more than 700,000 patients since its introduction. BYETTA is indicated as an add-on therapy for use twice a day in adults with type 2 diabetes who are unsuccessful at controlling their blood sugar levels using common oral diabetes medications. This study was conducted following receipt of an approvable letter for a monotherapy indication from the FDA in 2005.
The 24-week, randomized study included 232 people with type 2 diabetes who were not achieving adequate glucose control using diet and exercise without previous use of antidiabetes agents. Study participants were randomized to receive subcutaneous injections of placebo, 5 mcg exenatide, or 10 mcg exenatide twice daily without taking any oral antidiabetes agents. Patients randomized to 10 mcg exenatide received 5 mcg injections for the first 4 weeks, and increased to 10 mcg injections for the final 20 weeks.
Full study results will be included in future scientific publications.