Amylin Pharmaceuticals, Inc. and Eli Lilly and Company announced detailed findings from a study that showed Byetta (exenatide) injection lowered blood glucose levels for people with type 2 diabetes who had not achieved target blood glucose levels despite the use of a thiazolidinedione (TZD) with or without metformin.

Patients using Byetta showed improvements in three important measures of blood glucose control: fasting blood glucose, postprandial blood glucose and haemoglobin A1C (A1C), which improved by approximately 0.9 per cent compared to the control group. Sixty-two per cent of study participants using Byetta who completed the full study reached target A1C of 7 percent or less. Less than 7 per cent is the target for good glucose control as recommended by American Diabetes Association (ADA).

Byetta treatment also resulted in a reduction in average body weight. Byetta-treated patients lost an average of approximately three pounds of body weight, while those treated with placebo lost on average approximately one- half pound.

These findings were presented at the 66th Annual Scientific Sessions of the ADA in Washington, DC. Byetta (pronounced bye-A-tuh), was approved in April 2005 as an adjunctive therapy for patients with type 2 diabetes who are not achieving blood sugar control on metformin and/or a sulfonylurea.

"In the context of treating the underlying defects in people with type 2 diabetes -- beta-cell dysfunction and insulin resistance -- using combination therapies is a sensible approach for patients," said Bernard Zinman, MD, Director of the Leadership Sinai Centre for Diabetes, Mount Sinai Hospital in Toronto, Ontario and a lead author of the study. "These data indicate that the addition of Byetta to TZDs can be a clinically meaningful treatment for patients."

In the first quarter of 2006, Amylin and Lilly submitted a supplemental New Drug Application to the Food and Drug Administration seeking approval of Byetta as an add-on therapy to treatment with a TZD with or without metformin in patients with type 2 diabetes.

Byetta is the first incretin mimetic, a class of drugs for the treatment of type 2 diabetes. Byetta 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 regulate blood sugar.

Adverse events associated with Byetta are generally mild to moderate in intensity. In clinical trials, the most frequently reported adverse event was mild-to-moderate, dose-dependent nausea. With continued therapy, the frequency and severity of nausea decreased over time in most patients.

Patients receiving Byetta in combination with a sulfonylurea may be at a higher risk of hypoglycemia or low blood sugar. To reduce this risk, decreasing the dose of sulfonylurea may be considered. When patients begin taking Byetta, the symptoms, treatment and conditions that predispose development of hypoglycemia should be explained to them, and the patient's usual instructions for hypoglycemia management should be reviewed and reinforced.

Patients should also be advised that treatment with Byetta may lead to a reduction in appetite, food intake and/or body weight, and that there is no need to modify the dosing regimen due to such effects.

Byetta is not a substitute for insulin in insulin-requiring patients. Byetta should not be used in patients with type 1 diabetes. Use of Byetta is not recommended in patients with end-stage renal disease or severe renal impairment, or in patients with severe gastrointestinal disease. Byetta should be used with caution in patients receiving oral medications that require rapid gastrointestinal absorption.