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The FDA 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, or TZD. The drug was approved for use with two other diabetes treatments, metformin, sulfonylureas, in 2005.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 percent or less, compared to 16 percent 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, according to Amylin. The most common adverse event associated with BYETTA was nausea, which occurred in 40 percent of patients.

“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, D.C. “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 is designed to improve blood sugar control by lowering both post-meal and fasting, or 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. The drug is designed to restore the first-phase insulin response – an activity of the cells in the pancreas that is lost in patients who have type 2 diabetes, decrease glucose output from the liver, regulate gastric emptying, and decrease 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 of Amylin. “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.”

Amylin has a profit sharing agreemen with Eli Lilly for BYETTA. Amylin developed the drug and Eli Lilly has conducted its marketing. The companies split the US profits 50/50 and outside of the US, Amylin receives royalties. The new expanded FDA approval only covers the US.

Vince Mihalik, global brand development leader for diabetes and endocrine at Eli Lilly explained that there are two core defects to type 2 diabetes, beta cell failure and insulin resistance.

“The ability of BYETTA to improve beta cell responsiveness and lower weight complements the TZD effect on insulin resistance very nicely,” he said.

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, or GLP-1. GLP-1 improves blood sugar after food intake through multiple effects that work in concert on the intestine, liver, pancreas and brain. BYETTA is approved by the FDA for use by people with type 2 diabetes who are unsuccessful at controlling their blood sugar levels despite using the commonly prescribed oral medications metformin, a sulfonylurea, or a thiazolidinedione.