FDA Submission for monotherapy will be submitted in the first half of 2008.
Amylin Pharmaceuticals and Eli Lilly and Company announced study results from a 24-week study of Byetta monotherapy 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.
James Malone, M.D., Global Medical Director, Eli Lilly and Company, stated that, "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.
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.