Journal
DIABETES
Volume 69, Issue 8, Pages 1827-1832Publisher
AMER DIABETES ASSOC
DOI: 10.2337/db20-0166
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Funding
- National Institutes of Health through the National Institute of Diabetes and Digestive and Kidney Diseases
- National Institutes of Health through National Institute of Allergy and Infectious Diseases
- National Institutes of Health through Eunice Kennedy Shriver National Institute of Child Health and Human Development
- National Institutes of Health through National Center for Research Resources
- JDRF
- American Diabetes Association
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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 did not show efficacy overall and had type 1 diabetes as the primary end point were analyzed: the Diabetes Prevention Trial-Type 1 (DPT-1) and the TrialNet oral insulin trials. Oral glucose tolerance tests at baseline and after 1 year of treatment were analyzed. Among those at high risk (with a Diabetes Prevention Trial-Type 1 Risk Score [DPTRS] >= 6.75), the area under the curve (AUC) C-peptide increased significantly from baseline to 1 year in each oral insulin group, whereas the AUC glucose increased significantly in each placebo group. At 1 year, the AUC C-peptide/AUC glucose (AUC Ratio) was significantly higher in the oral insulin group than in the placebo group in each trial (P< 0.05;P= 0.057 when adjusted for age in the TrialNet trial) and in both trials combined (P< 0.01 with or without adjustment for age). For a DPTRS <6.75, oral insulin groups did not differ from placebo groups in the AUC Ratio. 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 end points can be useful adjuncts to the diagnostic end point in assessments of preventive treatments for the disorder.
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