Nov. 26, 2001 -- A new approach to treating diabetes shows promising results in small trials and may prevent the progression of the disease and ultimately reduce dependence on daily insulin injections.
According to the American Diabetes Association, 800,000 to 1.6 million Americans have Type 1 diabetes, also known as insulin-dependent diabetes. The disease is characterized by an inability to produce insulin that usually results when the body's own cells attack the insulin producing cells of the pancreas.
New research published in the journal Lancet suggests that this destructive process may be halted using a protein fragment known as DiaPep277.
In the study, one treatment group of 18 subjects received three injections of DiaPep in a six-month period and a second group of 17 subjects received equivalent injections of placebo. Both groups were followed for 10 months.
At ten months, subjects who received placebo showed a decrease in natural insulin production and an increase in their need for injected insulin. In contrast, subjects receiving DiaPep continued to produce consistent levels of insulin and required less injected insulin.
A New Approach
"When somebody develops Type 1 diabetes, we treat them with insulin to try and control their blood sugar," says Dr. Jerry Palmer, professor of medicine and director of the diabetes research center at the University of Washington, Seattle. "This is an intervention which is different from that."
Instead of replacing the insulin that is missing, DiaPep affects the underlying disease process.
"Since your own pancreas is still making some insulin, then the amount of insulin you would need to take to control your diabetes would be expected to be less," says Palmer.
However, DiaPep is not intended to eliminate the use of insulin altogether.
"The major therapeutic advantage for the patient would be delaying or preventing the secondary complications of diabetes," says Dana Elias, lead investigator of the study and vice president of research & development at Peptor - the Israeli biopharmaceutical company now developing the treatment.
"Diabetes causes a reduction in life-expectancy of 15 years, it is a leading cause of blindness, kidney failure and limb amputation in the western world. It also causes a tremendous increase in cardiovascular problems," adds Elias.
Implications and Cautions
This new approach may also be used to create a kind of a vaccine for high-risk individuals.
"If injections of DiaPep were to be done at an earlier stage when you had more residual ability to secrete insulin, then you might be able to block the progression to Type 1 diabetes," says Palmer, who plans to participate in larger US trials nowin the works.
DiaPep may also have implications for treating other autoimmune diseases. "If this concept works, then a similar approach should and could be used for other diseases like rheumatoid arthritis," says Elias.
Thus far, there have been no serious side effects associated with DiaPep use, but experts feel that larger studies with longer follow-up times are required before any strong conclusions are drawn.
"Sometimes the toxicity of the 'cure' can be worse than the disease itself," says Dr. Kenneth Copeland, Jonas professor of diabetes and endocrinology at the Oklahoma University Health Sciences Center in Oklahoma City.
"If indeed DiaPep277 is less toxic than other agents and if the effects can be sustained and if the effects are applicable to younger as well as older patients, then the observation has substantial ramifications," adds Copeland.