16 September 2026 editorial review · Trial
T1GER: Golimumab in youth with new-onset type 1 diabetes: review notes
These notes document the scope actually reviewed, including source-access limits. They are not independent clinical certification or a guarantee that every claim was verified.
Read the trial evidence page →Primary-agent trial review — 16 September 2026
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: NCT02846545; COMPLETED; updated 2025-02-04; enrollment 84 (ACTUAL); results posted.
Endpoint comparison: Active Treatment Period: C-peptide Area Under the Concentration-time Curve (AUC) Calculated From a 4 Hour Mixed Meal Tolerance Test (MMTT) at Week 52 (Week 52).
Sources for this record: Golimumab and Beta-Cell Function in Youth with New-Onset Type 1 Diabetes (peer-reviewed); A Study of SIMPONI to Arrest Beta-cell Loss in Type 1 Diabetes (registry).
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.
Selected cell-therapy and adjunct trial review — 16 September 2026
Outcome and correction: Removed old-map editorial history; retained 84 participants, C-peptide .64 vs .43, P<.001, lower insulin and similar HbA1c. Added autoantibody/C-peptide criteria and relevant hypoglycemia adverse-event/anti-drug antibody findings.
Primary sources checked: NEJM primary abstract; Registry NCT02846545.
Limits: Abstract-level outcome review; no new long-term efficacy or safety claim. Distinguishes investigator-recorded hypoglycemia adverse events from overall mean event counts.