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PubMed ID:
32439823
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.
DOI:
https://doi.org/10.2337/db20-0166
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
Request IDs:
20565
,
21294
Studies:
Diabetes Prevention Trial of Type 1 Diabetes
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.
