Treatment Preserves Insulin-Making Cells in Type 1 Diabetes

Patients needed less insulin to treat their disease, researchers say

WEDNESDAY, June 22, 2005 (HealthDay News) -- Treatment with a monoclonal antibody, a new type of therapy, may help preserve insulin-making abilities in people who have recently developed type 1 diabetes.

New European research shows that just one six-day course of the experimental treatment resulted in improvements lasting 18 months.

Type 1 diabetes is an autoimmune disease caused by T lymphocyte cells targeting and destroying insulin-producing beta-cells in the pancreas. About five percent of all diabetics carry the type 1 form of the disease, which is usually diagnosed in childhood or adolescence.

The success of the new therapy "clearly shows that our understanding of the basic science is beginning to translate into clinical application," said Dr. Stuart Weiss, a clinical assistant professor of medicine at New York University School of Medicine in New York City. "If the treatment is started before the greater portion of insulin-producing cells are destroyed, there can be a significant delay in the progression of beta-cell destruction, and that's very exciting."

"This is the start of a fast forward to begin to talk about the possibility of stopping the progression of an autoimmune disease, and about reversing the disease," added Dr. Richard Insel, executive vice president of research at the Juvenile Diabetes Research Foundation, which sponsored the trial.

Eventually, Insel said, this type of therapy, combined with a method of regenerating the body's insulin-making abilities, might lead to a cure.

The study was led by researchers at Brussels Free University and is published in the June 23 issue of the New England Journal of Medicine.

The new therapy relies on the fact that people with type 1 diabetes do not lose their ability to make insulin all at once. "Diabetes is preceded by an incubation period that can be as short as months or as long as over a decade," Insel explained. "Overt diabetes does not occur until the beta cell reserves fall by about 80 percent."

The researchers sought to intervene before reserves hit that 80 percent mark. Eighty patients with new-onset type 1 diabetes were randomly assigned to receive either a new antibody or a placebo for six consecutive days.

The antibody was directed against CD3 (ChAglyCD3), a molecule on the surface of T-cells. The antibody does not actually kill the T-cells, Insel explained, but rather "resets" them.

People who received the antibody had higher residual beta-cell function than people who received the placebo. Although no participants were able to give up insulin altogether, people in the antibody group needed less insulin, while people in the placebo group needed increasing amounts of the hormone as time wore on.

The antibody also worked better on people who started with a higher level of beta-cell function (50 percent or more).

There was one notable side effect: the antibody produced flu-like symptoms and symptoms of Epstein-Barr viral mononucleosis.

And, the study's lead author pointed out, the research only involved adults.

"We need more patients in studies to document the long-term safety of our treatment. We also have to study children," said Dr. Bart Keymeulen, of the Juvenile Diabetes Research Foundation Center for Beta Cell Therapy at the Medical Campus of Brussels Free University in Belgium.

Also, he added, at this point, patients will have to continue to take insulin.

"Subcutaneous insulin treatment cannot be stopped, because with this treatment, there is no increase in residual beta cell function," Keymeulen said.

"[The antibody] could be a great help for this subgroup of patients to maintain their production of their own insulin," added Dr. Ake Lernmark, author of an accompanying editorial and professor of medicine at the University of Washington in Seattle. "They would have to take insulin, but in much reduced quantity."

Even though the therapy isn't ready for "prime time," it does point up the importance of early diagnosis.

"This treatment would be available to patients who are diagnosed early in the course of their diabetes so they still have some function left," Lernmark said. "It will be like cancer treatment, where the cancer has not progressed."

More information

The Juvenile Diabetes Research Foundation has more on type 1 diabetes.

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