Genetically Engineered Hormone May Help Fight Diabetes

Early trial shows it controls insulin levels, even helps diabetics lose weight

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HealthDay Reporter

FRIDAY, March 8, 2002 (HealthDayNews) -- Genetically engineered versions of a natural hormone hold promise as a treatment for severe cases of Type II diabetes, the kind that begins in midlife when the body's production of insulin falters.

The hormone, glucagon-like peptide 1 (GLP-1), offered excellent control of blood sugar levels in a Danish trial, according to a new report in The Lancet. It also helped participants lose weight.

Perhaps most important, GLP-1 appears to stimulate growth of beta cells, which produce insulin. It one day might help diabetics reduce their reliance on medication, says Dr. Jens Juul Holst, study author and a professor of medical physiology at the Panum Institute in Copenhagen.

"There was a very significant effect in every one of the diabetes patients we looked at," Holst says.

The trial included 20 patients with Type II diabetes. Half took a continuous infusion of GLP-1 for six weeks, while the other half received a placebo. Tests showed "a profound improvement of metabolic regulation during treatment" with GLP-1, Holst says, in part because the hormone increased the effectiveness of the body's limited production of insulin. The hormone converts sugar to energy in the body.

GLP-1 can't be taken orally. In the Danish study, participants received the hormone by continuous infusion, using a miniature pump similar to that used for insulin therapy. The benefits of GLP-1 make that inconvenience worthwhile, Holst says.

Restoragen Inc., a biotechnology company based in Lincoln, Neb., supplied the hormone for the Danish study. A multi-center U.S. trial that will include 100 participants at 25 to 40 sites has begun recruiting people, says Dr. Mario Ehlers, the company's senior vice president for business development.

"We are focusing on the group of patients who have failed to control their condition using two first-line [drugs]," Ehlers says. Those patients must either go on to more advanced medications or start insulin injections.

For those patients, GLP-1 "has the same inconvenience as insulin but is safer," Ehlers contends.

"GLP-1 only stimulates insulin production when blood glucose levels are elevated, so there is a self-regulating mechanism," he says. By contrast, an insulin injection always reduces blood glucose levels, so there's a risk of too great a reduction, he says.

Results of the U.S. trial will help Restoragen decide whether to move on to more advanced studies aimed at winning U.S. Food and Drug Administration approval of the hormone therapy. The company is seeking a partner because it doesn't have the money to test and market the product on its own, he says.

Restoragen is in a race with two larger companies, including Eli Lilly & Co., which have their own versions of GLP-1. Those versions can be taken by injection, once or several times a day, rather than by continuous infusion, Ehlers says.

The potential market is the 30 percent to 40 percent of people with Type II diabetes who either must take multiple oral drugs or have insulin injections, Ehlers says.

If GLP-1 lives up to its early promise, it could be used to help treat people with Type I diabetes, in which there is no natural production of insulin, he says.

"Because of its effect on beta cells, it could potentially restore some function in Type I diabetes," Ehlers explains.

What To Do: To learn more about diabetes, its symptoms and treatment, visit the American Diabetes Association. To learn more about controlling diabetes, visit The National Institute of Diabetes and Digestive and Kidney Diseases.

SOURCES: Interviews with Jens Juul Holst, M.D., professor, medical physiology, Panum Institute, Copenhagen, Denmark; Mario Ehlers, M.D., Ph.D, senior vice president, business development, Restoragen Inc., Lincoln, Neb.; March 8, 2002, The Lancet

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