Amylin Pharmaceuticals Inc and Eli Lilly and Company achieved 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.

A1C, a measure of glucose control over the previous three months, improved by approximately 0.9 per cent points 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 approximately 7.9 per cent. Sixty-two per cent of subjects receiving Byetta who entered the study with an A1C greater than 7 per cent achieved an A1C of 7 per cent or less compared to 16 per cent of similar subjects on placebo. The American Diabetes Association recommends a target A1C of less than 7 per cent, claims a company release.

Compared to placebo, subjects receiving Byetta experienced an average weight reduction of approximately three pounds at 16 weeks.

The most common adverse event was nausea, which occurred in 40 per cent of subjects receiving Byetta compared to 15 per cent of those receiving TZD with placebo. No severe hypoglycaemia was observed.

These results are consistent with those seen in the Amigo studies for Byetta when Byetta was added to other commonly prescribed oral medications.

This randomised, placebo-controlled, double-blind study included 233 subjects with type 2 diabetes who were not achieving adequate glucose control using a TZD, a common oral diabetes medication, either alone or with metformin. Subjects were randomised to receive Byetta or placebo for 16 weeks in addition to their usual TZD regimen. Those receiving Byetta received an introductory 5-microgram dose of Byetta for one month, given by subcutaneous injection twice a day, followed by three months of 10 micrograms given twice a day. Amylin and Lilly anticipate that the full study results will be presented in a future scientific forum.

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). GLP-1, secreted in response to food intake, has multiple effects on the intestine, liver, pancreas and brain that work in concert to improve blood sugar.

Incretin mimetics is a new class of treatment in the fight against diabetes. An incretin mimetic works to mimic the anti-diabetic or glucose-lowering actions of naturally occurring human hormones called incretins. These actions include stimulating the body's ability to produce insulin in response to elevated levels of blood sugar, inhibiting the release of a hormone called glucagon following meals, slowing the rate at which nutrients are absorbed into the bloodstream and reducing food intake. Byetta is the first FDA-approved agent of this new class of medications.