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Monotherapy BYETTA® Showed Significant Improvement in Glucose Control

Posted: Thursday, December 13, 2007

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.

Source: Diabetes In Control