Byetta Approved for Use with TZD’s in Type 2 Diabetes

Amylin and Eli Lilly announced last Friday that the FDA has approved BYETTA(R) (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 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. The most common adverse event associated with BYETTA was nausea (40 percent)(1)(2).

"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."

The combination should be very complementary (even synergistic) because it will work on both defects in type 2 diabetes – insulin resistance and insulin secretion. TZDs confer insulin sensitivity, vascular protection, and other fairly impressive metabolic benefits while Byetta improves insulin secretion, reduces hepatic glucose output, and slows gastric emptying. Back in June at ADA an abstract was presented #117. Briefly, this was a 233-subject trial of type 2 diabetes patients not at goal on a TZD with or without metformin. After 16 weeks, 62% of patients who added Byetta achieved A1c < 7% compared to 16% of placebo patients. Patients on Byetta lost 3.3 lb compared to a 0.4 lb loss on placebo. Only 20% were on a TZD alone – the rest were on both a TZD and metformin. One of the best aspects of a Byetta and TZD combination is the
likelihood that Byetta mitigates or even cancels the weight gain usually experienced on TZDs.

For full prescribing information, visit www.BYETTA.com.

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DID YOU KNOW:
UN passes resolution stating that diabetes a global threat: Puts it in league with AIDS. Last week, the United Nations General Assembly passed a resolution recognizing the global threat of the diabetes epidemic and encouraged governments to take action against the disease. The resolution designates World Diabetes Day, Nov. 14, as a United Nations Day to be observed starting in 2007. The much-ignored but deadly disease is responsible for close to 4 million deaths every year. See this week’s Item #15