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Health

Diabetes drug stems from Gila monster spit

By wire services
Published April 30, 2005

WASHINGTON - Type 2 diabetics got a new option to help control their blood sugar Friday, a drug derived from the saliva of the Gila monster - but one that must be injected twice a day.

The Food and Drug Administration approved Byetta, known chemically as exenatide, the first in a new class of medications for Type 2 diabetes. For now, it's supposed to be used with older diabetes drugs, not alone.

Makers Amylin Pharmaceuticals and Eli Lilly & Co. said the prescription drug would begin selling by June 1 but wouldn't provide a price.

Some 18-million Americans have diabetes, and the vast majority have the Type 2 form, in which the body loses the ability to turn blood sugar into energy because it either doesn't produce enough insulin or doesn't use it correctly. It is closely associated with obesity.

When diet and exercise aren't enough to control Type 2 diabetes, patients can try certain oral medications to lower blood sugar. The most common drugs, sulfonylureas, spur the body to produce more insulin.

When those drugs fail, adding Byetta to them offers patients a new option to try before resorting to injections of insulin.

Byetta is the first so-called "incretin mimetic," meaning it mimics action of a hormone that's secreted by the gut to spur insulin production after a meal - but only when blood sugar is high.

Byetta is a synthetic version of a protein found in the saliva of the Gila monster.

In studies, Byetta was given in addition to sulfonylureas, another common diabetes drug called metformin, or a combination of the older treatments.

The most common side effect was nausea. Also, patients who take Byetta with a sulfonylurea may need doses of that older drug reduced to avoid hypoglycemia, the manufacturers said.

The FDA encouraged the manufacturers to submit additional studies to show whether Byetta could eventually become a stand-alone treatment for Type 2 diabetes.

Japanese researchers have for the first time cured diabetes with a pancreatic cell transplant from a living donor, according to a report last week in the international medical journal, the Lancet.

Implants of insulin-secreting islet cells from cadaver pancreases are an increasingly common procedure in the United States and have been shown to provide long-lasting freedom from insulin shots. A successful implant usually requires islet cells from at least two cadavers.

On Jan. 19, Dr. Shinichi Matsumoto and his colleagues at the Kyoto University Hospital removed half the pancreas from a 56-year-old woman, harvesting the islet cells, and then implanting them into the woman's 27-year-old daughter. The daughter had required insulin shots for 12 years and her diabetes was very poorly controlled.

They gradually weaned her off insulin and, 22 days after the surgery, she became insulin-independent, Matsumoto reported.

The woman has remained insulin-free ever since, he said, but long-term follow-up will be necessary.

The technique could prove useful in Japan, where organ donations after death are rare because of cultural considerations. It could also have some utility in the United States - where it has been unsuccessfully attempted twice - because of a continuing shortage of pancreases from cadavers.

Information from the Associated Press and the Los Angeles Times was used in this report.

[Last modified April 30, 2005, 01:11:21]