Amylin Pharmaceuticals Inc. and Eli Lilly and Company announced that the US Food and Drug Administration (FDA) has approved Byetta (exenatide) injection as an add-on therapy to improve blood sugar control in people with type 2 diabetes who have not achieved adequate control on a thiazolidinedione (TZD). Healthcare professionals will be educated on this additional use for Byetta in the coming weeks.

In a clinical trial designed to evaluate Byetta for use in combination with a TZD, 62 percent of patients who added Byetta to their existing medicines achieved an A1C (a measure of blood glucose levels over time) of 7 per cent or less, compared to 16 per cent of the patients on placebo. People taking Byetta also lost an average of 3.3 pounds over 16 weeks, compared to an average weight reduction of 0.4 pounds in the other group. The most common adverse event associated with Byetta was nausea (40 per cent).

"Due to the progressive nature of type 2 diabetes, previous approaches to management frequently failed to achieve target levels of A1C, or resulted in subsequent failure over one to three years," said Dr Robert Ratner, vice president for scientific Affairs at the MedStar Research Institute in Washington, DC. "The combination of exenatide with metformin, sulfonylureas, or TZDs not only expands our options to achieve optimal glycemic control, but does so with accompanying weight loss."

Byetta improves blood sugar control by lowering both post-meal and fasting (early morning) glucose levels resulting in better long-term control as measured by A1C. Byetta controls blood sugar through several physiologic actions, including the stimulation of insulin secretion only when blood sugar is high.

Byetta restores the first-phase insulin response (an activity of the cells in the pancreas that is lost in patients who have type 2 diabetes), decreases glucose output from the liver, regulates gastric emptying, and decreases food intake. The majority of patients in long-term Byetta clinical studies also experienced weight loss.

"Almost half a million people with type 2 diabetes have used Byetta to help reduce their blood sugar," said Ginger L. Graham, chief executive officer, Amylin Pharmaceuticals. "Now, even more people -- those who use another common category of oral medicines, TZDs -- have a new treatment option and have the opportunity to benefit from the unique clinical benefits of Byetta."

"There are two core defects to type 2 diabetes, beta cell failure and insulin resistance," said Vince Mihalik, Global Brand Development Leader for Diabetes and Endocrine, Lilly. "The ability of Byetta to improve beta cell responsiveness and lower weight complements the TZD effect on insulin resistance very nicely."

Byetta is the first in a new class of drugs for the treatment of type 2 diabetes called incretin mimetics. Byetta exhibits many of the same effects as the human incretin hormone glucagon-like peptide-1 (GLP-1). GLP-1 improves blood sugar after food intake through multiple effects that work in concert on the intestine, liver, pancreas and brain.