The National Institutes of Health, the Juvenile Diabetes Foundationand the American Diabetes Association are co-sponsoring a multiyearstudy to determine whether injectable or oral administration ofinsulin can prevent the onset of Type I diabetes.
Eli Lilly and Co., which is supplying the insulin for the study,announced Tuesday that 60,000 to 80,000 people will be screened torecruit 830 study participants. The volunteers will be screened fortwo antibodies that have been associated with the development ofType I diabetes.
Depending on the level of antibodies present in their system, studyparticipants will be assigned to one of two trials. Those at a higherrisk of developing the disease will receive daily injections of Lilly'srecombinant insulin, Humulin Ultralente, and an annual infusion ofregular insulin. Those at lower risk of developing diabetes will takepart in a second trial, where they will receive insulin crystals orally.The insulin injection trial will begin immediately and the oral insulintrial will start in 1995.
Insulin is approved for the treatment of diabetes. Howard Weiner, aphysician at Brigham and Women's Hospital in Boston, told BioWorldthat a pilot study suggested that those at risk of developing diabeteswho received injections of small amounts of insulin "may not developdiabetes as readily" as they would without the insulin. Weiner, whois also AutoImmune Inc.'s chief scientific adviser, said this effectmight relate to resting the insulin-producing beta cells in thepancreas so they are not as susceptible to attack by white bloodcells."
Weiner explained that use of oral insulin is based on the concept oforal tolerance, whereby feeding a patient insulin suppresses diabetesthrough an immunologic mechanism. This probably works bygenerating regulatory cells that decrease inflammation in the betacells, he said. AutoImmune has filed patents on the oral tolerancetechnology and is using this approach in developing treatments formultiple sclerosis and rheumatoid arthritis.
AutoImmune (NASDAQ:AIMM) of Lexington, Mass., is providingfunds for the Phase I oral insulin trial and helping investigators planthe trial design.
-- Brenda Sandburg News Editor
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