16 September 2026 editorial review · Trial
Imatinib in recent-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: NCT01781975; COMPLETED; updated 2020-02-11; enrollment 67 (ACTUAL); results posted.
Endpoint comparison: Area Under the Stimulated C-peptide Curve (AUC) Mean Over the First 2 Hours of a 4 Hour Mixed Meal Tolerance Test at the 1 Year Visit (Visit 9 (Week 52) at 0, 15, 30, 60, 90, 120 minutes post-dose).
Sources for this record: Imatinib therapy for patients with recent-onset type 1 diabetes (peer-reviewed); Imatinib Treatment in Recent Onset Type 1 Diabetes Mellitus (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 historical trial audit
Correction: 67 randomized, 64 contributing to 12-month analysis. Added adjusted C-peptide estimate, the one-tailed p=0.048 and 90% interval crossing zero; benefit not sustained at month 24 after randomization, rather than 24 months after treatment ended. Added adverse events and temporary/permanent treatment modifications, which materially constrain benefit interpretation.
Sources: Primary Lancet Diabetes & Endocrinology abstract, registry.
Limit: Primary abstract reviewed; supplementary analyses not independently reproduced. Meeting the prespecified one-tailed test is not equivalent to a conventional two-sided result.