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Slowed Metabolic Decline after One Year of Oral Insulin Treatment among Individuals at High Risk for Type 1 Diabetes in the Diabetes Prevention Trial-Type 1 and TrialNet Oral Insulin Prevention Trials

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posted on 21.05.2020, 22:26 by Ada Admin, Jay M. Sosenko, Jay S. Skyler, Kevan C. Herold, Desmond A. Schatz, Michael J. Haller, Alberto Pugliese, Mario Cleves, Susan Geyer, Lisa E. Rafkin, Della Matheson, Jerry P. Palmer, Type 1 Diabetes TrialNet Study Group
We assessed whether oral insulin slowed metabolic decline after 1 year of treatment in individuals at high risk for type 1 diabetes. Two oral insulin trials that were negative overall with type 1 diabetes as the primary endpoint were analyzed: the Diabetes Prevention Trial-Type 1 (DPT-1) and TrialNet oral insulin trials. Oral glucose tolerance tests at baseline and after 1 year of treatment were analyzed. Among those at high risk [Diabetes Prevention Trial Risk Score (DPTRS)≥6.75], the AUC C-peptide increased significantly from baseline to 1 year in each oral insulin group, whereas AUC glucose increased significantly in each placebo group. At 1 year, AUC C-peptide/AUC glucose was significantly higher (p<0.05) in the oral insulin group than in the placebo group in each trial (p=0.057 with age adjustment in the TrialNet trial; p<0.01 for trials combined with or without age adjustment). For DPTRS<6.75, oral insulin groups did not differ from placebo groups. The findings suggest that 1 year of treatment with oral insulin slows metabolic deterioration in individuals at high risk for type 1 diabetes. Moreover, the findings further suggest that metabolic endpoints can be useful adjuncts to the diagnostic endpoint in assessments of preventive treatments for the disorder.


This work was funded by the National Institutes of Health through the National Institute of Diabetes and Digestive and Kidney Diseases, the National Institute of Allergy and Infectious Diseases, the Eunice Kennedy Shriver National Institute of Child Health and Human Development, and the National Center for Research Resources, JDRF, and the American Diabetes Association.



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