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16 September 2026 editorial review · Trial

Denosumab for beta-cell function in T1D: 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.

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Baseline trial evidence review: A–H

Outcome: Replaced vague early-T1D label with actual1–5year duration, sex-specific minimum age and C-peptide entry criteria; named actual safety/efficacy endpoints.

Registry: NCT06524960. Registered endpoint checked: Primary safety endpoint (up to 12 months); Primary efficacy endpoint (up to 12 months). Eligibility check: Registry age 18 Years to 50 Years; substantive diagnosis/stage, device and other inclusion restrictions were compared with the public eligibility summary. The registry remains the source for full exclusions. Limits: No usable primary abstract was independently recovered in this pass for this record. Protocol/design wording was assessed; any existing detailed sponsor, conference or historical outcome claims require their cited source and were not independently certified through full-text review.

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