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- Title
Effects of oral insulin in relatives of patients with type 1 diabetes: The Diabetes Prevention Trial--Type 1.
- Authors
Diabetes Prevention Trial-Type 1 Study Group; Skyler, Jay S; Krischer, Jeffrey P; Wolfsdorf, Joseph; Cowie, Catherine; Palmer, Jerry P; Greenbaum, Carla; Cuthbertson, David; Rafkin-Mervis, Lisa E; Chase, H Peter; Leschek, Ellen
- Abstract
<bold>Objective: </bold>This randomized, double-masked, placebo-controlled clinical trial tested whether oral insulin administration could delay or prevent type 1 diabetes in nondiabetic relatives at risk for diabetes.<bold>Research Design and Methods: </bold>We screened 103,391 first- and second-degree relatives of patients with type 1 diabetes and analyzed 97,273 samples for islet cell antibodies. A total of 3,483 were antibody positive; 2,523 underwent genetic, immunological, and metabolic staging to quantify risk of developing diabetes; 388 had a 5-year risk projection of 26-50%; and 372 (median age 10.25 years) were randomly assigned to oral insulin (7.5 mg/day) or placebo. Oral glucose tolerance tests were performed every 6 months. The median follow-up was 4.3 years, and the primary end point was diagnosis of diabetes.<bold>Results: </bold>Diabetes was diagnosed in 44 oral insulin and 53 placebo subjects. Annualized rate of diabetes was similar in both groups: 6.4% with oral insulin and 8.2% with placebo (hazard ratio 0.764, P = 0.189). In a hypothesis-generating analysis of a subgroup with insulin autoantibody (IAA) levels confirmed (on two occasions) > or =80 nU/ml (n = 263), there was the suggestion of benefit: annualized diabetes rate 6.2% with oral insulin and 10.4% with placebo (0.566, P = 0.015).<bold>Conclusions: </bold>It is possible to identify individuals at high risk for type 1 diabetes and to enroll them in a large, multisite, randomized, controlled clinical trial. However, oral insulin did not delay or prevent type 1 diabetes. Further studies are needed to explore the potential role of oral insulin in delaying diabetes in relatives similar to those in the subgroup with higher IAA levels.
- Publication
Diabetes Care, 2005, Vol 28, Issue 5, p1068
- ISSN
0149-5992
- Publication type
Academic Journal
- DOI
10.2337/diacare.28.5.1068