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Publication Information

PubMed ID
Public Release Type
Journal
Publication Year
2020
Affiliation
University of Miami Miller School of Medicine, Miami, FL jsosenko@med.miami.edu.; University of Miami Miller School of Medicine, Miami, FL.; Yale University School of Medicine, New Haven, CT.; University of Florida Diabetes Institute, Gainesville, FL.; University of Florida Diabetes Institute, Gainesville, FL.; University of Miami Miller School of Medicine, Miami, FL.; University of South Florida, Tampa, FL.; University of South Florida, Tampa, FL.; University of Miami Miller School of Medicine, Miami, FL.; University of Miami Miller School of Medicine, Miami, FL.
Authors
Sosenko Jay M, Skyler Jay S, Herold Kevan C, Schatz Desmond A, Haller Michael J, Pugliese Alberto, Cleves Mario, Geyer Susan, Rafkin Lisa E, Matheson Della, Palmer Jerry P
Studies

Abstract

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.