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Amylin Pharmaceuticals, Lilly announce positive results of Byetta for diabetes
By Ted A. Knutson
Washington, Nov. 15 - Amylin Pharmaceuticals Inc. and Eli Lilly and Co. on Tuesday announced positive results from a study of Byetta (exenatide) injection used in addition to a common class of oral diabetes medication called thiazolidinediones (or TZDs), in people with Type 2 diabetes who were not achieving acceptable blood sugar control.
Results from this study will form the basis of a supplemental New Drug Application submission to the Food and Drug Administration, currently planned for mid 2006, the company said in a news release.
A1C, a measure of glucose control over the previous three months, improved by about 0.9% at the end of the 16-week study for subjects receiving twice daily 10 microgram subcutaneous injections of Byetta in addition to their usual TZD or TZD plus metformin regimen, compared to those on their prior oral medications receiving placebo.
At the beginning of the study, the average A1C of study participants was about 7.9%. And 62% of subjects receiving Byetta who entered the study with an A1C greater than 7% achieved an A1C of 7% or less compared with 16% of similar subjects on placebo.
The American Diabetes Association recommends a target A1C of less than 7%.
Compared to placebo, subjects receiving Byetta experienced an average weight reduction of about three pounds at 16 weeks, according to the study.
These results are consistent with those seen in the Amigo studies for Byetta when Byetta was added to other commonly prescribed oral medications.
Byetta is the first in a new class of drugs for the treatment of Type 2 diabetes called incretin mimetics and exhibits many of the same effects as the human incretin hormone glucagon-like peptide-1 (GLP-1).
Amylin is a San Diego-based pharmaceutical company. Eli Lilly is an Indianapolis-based drug manufacturer.
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