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- Title
Slowed Metabolic Decline After 1 Year of Oral Insulin Treatment Among Individuals at High Risk for Type 1 Diabetes in the Diabetes Prevention Trial-Type 1 (DPT-1) and TrialNet Oral Insulin Prevention Trials.
- 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.; Type 1 Diabetes TrialNet Study Group
- 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.
- Subjects
TYPE 1 diabetes; INSULIN; GLUCOSE tolerance tests; PLACEBOS; DIABETES; INSULIN therapy; THERAPEUTIC use of monoclonal antibodies; BLOOD sugar; C-peptide; COMPARATIVE studies; RESEARCH methodology; MEDICAL cooperation; PHARMACOKINETICS; RESEARCH; EVALUATION research; RANDOMIZED controlled trials
- Publication
Diabetes, 2020, Vol 69, Issue 8, p1827
- ISSN
0012-1797
- Publication type
journal article
- DOI
10.2337/db20-0166