Studies yield key insights in preventing destruction of insulin-produ...( ers for type 1 diabetes risk how the l...),Health

The trial compared insulin injections and close observation in high-risk people whose ability to make insulin was below normal, though they did not yet have diabetes. Half the participants were randomized to receive low-dose insulin injections twice a day under the skin. Once a year, they also received a 4-day course of low-dose, continuous intravenous insulin. The other half received no treatment but were closely observed throughout the trial, which began in 1995. Participants' ages ranged from 4 to 45 years old, with a median age of 11 years. After 5 years of observation, nearly 60 percent of participants developed type 1 diabetes, a rate of diabetes onset that was virtually identical in both groups.

A separate trial is currently testing whether insulin taken by mouth can prevent or delay type 1 diabetes in people at an earlier stage in the development of diabetes. The ongoing trial targets people who have evidence of autoimmunity but no significant loss in their ability to produce insulin. These individuals have a lower (25 to 50 percent) risk of developing diabetes in 5 years. The oral insulin trial is based on a different immune mechanism, so the results of the injection trial do not predict the outcome of the oral trial. In contrast to insulin injections, insulin taken by mouth does not affect blood glucose. Rather, it targets the immune response to down regulate the immune cells that attack the insulin-producing beta cells of the pancreas. Patient recruitment for the oral trial is nearly complete, and enrollment is scheduled to end in August. The other study published in the NEJM was an early-phase clinical trial that tested an experimental drug with selective immunosuppressive effects in patients with newly diagnosed type 1 diabetes. The drug, a modified form of anti-CD3 antibody that
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Contact: Joan Chamberlain
301-496-3583
NIH/National Institute of Diabetes and Digestive and Kidney Diseases
29-May-2002