TN-07: Oral insulin for prevention in autoantibody-positive relatives: review notes

Assessment: Summary, current status, primary endpoint and key eligibility compared with the current registry. No additional discrepancy confirmed in that comparison. Historical outcome details beyond the primary sources explicitly discussed in the specialist ledgers were not all independently reverified.

Registry: NCT00419562; COMPLETED; updated 2020-05-07; enrollment 560 (ACTUAL); results posted.

Endpoint comparison: Rate of Type 1 Diabetes Per Year Among Individuals in the Primary Stratum When Treated With Oral Inulin Versus Placebo (Metabolic and immunological tests were conducted every 6 months; participants were followed for a median of 2.7 years).

Sources for this record: Krischer JP, Schatz DA, Bundy B, Skyler JS, Greenbaum CJ; Writing Committee for the Type 1 Diabetes TrialNet Oral Insulin Study Group. Effect of Oral Insulin on Prevention of Diabetes in Relatives of Patients With Type 1 Diabetes: A Randomized Clinical Trial. JAMA (2017);318(19):1891–1902 (peer-reviewed); National Institute of Diabetes and Digestive and Kidney Diseases (TrialNet). Oral Insulin for Prevention of Diabetes in Relatives at Risk for Type 1 Diabetes Mellitus (TN07). ClinicalTrials.gov, NCT00419562 (registry); Oral Insulin Delay of Stage 3 Type 1 Diabetes Revisited in HLA DR4-DQ8 Participants in the TrialNet Oral Insulin Prevention Trial (TN07). (peer-reviewed); Source: 2664040 (peer-reviewed).

Limits: Source access and review depth vary. Registry fields establish the registered study, not clinical benefit, product approval or current local access. Cited-source reachability alone was not treated as verification of its claims.

Correction: Retained negative primary outcome and prespecified secondary-stratum identity, but labeled secondary analyses exploratory because of absent multiplicity adjustment. Removed teplizumab relationship and categorical safety wording. Replaced inconsistent subgroup percentages with published event counts (13 oral-insulin, 19 placebo), n=55 and reported HR 0.45.

Sources: Primary JAMA paper, 2024 post-hoc primary analysis, registry.

Source inconsistency: Original abstract itself reports 48.1% and 70.3%; publisher Table 1 gives oral n=28 and placebo n=27. The oral percentage does not reconcile with 13/28. Do not silently substitute a recalculated rate or pretend the original abstract never reported those percentages. Main-group and 2024 post-hoc hazard ratios were checked against abstracts; the latter remains hypothesis-generating.