SATURDAY, June 5, 2004 (HealthDayNews) -- A new type 2 diabetes drug derived from the saliva of a huge, venomous lizard may control blood sugar without the weight gain associated with other diabetes medications.
The trial drug, which has not yet won approval from the U.S. Food and Drug Administration, "will mean a new method, a novel treatment for type 2 diabetes patients, the likes of which we have not seen before," said Dr. Dennis Kim, director of clinical affairs for Amylin Pharmaceuticals in San Diego, which funded the study and makes the medication.
The findings were presented June 5 at the annual meeting of the American Diabetes Association in Orlando, Fla.
The origin of the novel drug, called exenatide, is itself novel. It is a synthetic version of the hormone exendin-4, found in the saliva of the Gila monster, a lizard native to several Southwestern U.S. states. The Gila monster eats just four times a year and turns its pancreas off between those meals. When it's time to turn its pancreas on again, it secretes exendin-4.
The exendin-4 is similar in action to human GLP-1, a hormone produced in the gut that can stimulate insulin production without causing threateningly low blood sugar, which can occur after taking insulin and some oral anti-diabetes pills.
Unlike other oral agents taken for type 2 diabetes, the drug has not been linked with weight gain and actually resulted in weight loss, according to the researchers.
"This class of drugs has been shown to suppress appetite in humans," Kim said.
More than 18 million Americans have diabetes, and most suffer from type 2, in which the body fails to use insulin properly.
In the study, exenatide was given to 336 people whose type 2 diabetes was not controlled well with the maximum doses of metformin (Glucophage), a commonly used oral drug for type 2 diabetes. The study, which lasted 30 weeks, involved three groups, receiving five micrograms or 10 micrograms of exenatide or placebo, injected twice daily.
Those on exenatide lost weight and reduced blood sugar, said Dr. Ralph DeFronzo, a physician at the University of Texas Health Science Center at San Antonio, who was to present the research at the meeting. Those on the higher dose lost 6.3 pounds on average and reduced their blood sugar levels. Those on the lower dose lost an average of 3.5 pounds and also lowered their blood sugar.
The most common side effects were mild to moderate nausea.
In animal studies, when exenatide was given, the formation of new beta cells resulted. Beta cells are the insulin-producing cells in the pancreas, and as type 2 diabetes progresses, they begin to fail. In the human study, markers of beta-cell function improved in those on the exenatide.
"If everything goes as planned, we foresee being able to market the drug the middle of next year, hopefully," Kim said.
Other experts agree the drug may be good news for type 2 diabetics. "The drug is acting like the hormone GLP, which is a gut hormone, and GLP is having a direct effect on the beta cells and causing the beta cells to secrete more insulin," said Dr. Martin Abrahamson, acting chief medical officer for the Joslin Diabetes Center in Boston, who serves on the scientific advisory board of Amylin.
In type 2 diabetes, Abrahamson said, there is a gradual loss of beta cell function over time. "Will the drug reverse that decline? We don't know the answer to that."
"This is a drug that will help control blood sugar, but [also] help with weight reduction," added Dr. Nathaniel Clark, a spokesman for the American Diabetes Association, who is familiar with the research on exenatide.
More information
To learn more about type 2 diabetes, visit the American Diabetes Association.
