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16 September 2026 editorial review · Trial

TN-10: Teplizumab to delay clinical type 1 diabetes in at-risk relatives (Stage 2): 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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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: NCT01030861; COMPLETED; updated 2020-08-05; enrollment 76 (ACTUAL); results posted.

Endpoint comparison: Rate of New Diabetes Per Year (During follow-up, median 745 days, range 74 to 2683).

Sources for this record: An Anti-CD3 Antibody, Teplizumab, in Relatives at Risk for Type 1 Diabetes. (peer-reviewed); U.S. Food and Drug Administration. FDA approves first drug that can delay onset of type 1 diabetes (FDA Update, Jan 1, 2023; original approval Nov 17, 2022) (regulatory); National Library of Medicine. AntiCD3 Mab (Teplizumab) For Prevention of Diabetes In Relatives At-Risk for Type 1 Diabetes Mellitus (NCT01030861). ClinicalTrials.gov (registry); Teplizumab improves and stabilizes beta cell function in antibody-positive high-risk individuals. (peer-reviewed); U.S. Food and Drug Administration. Drug Trials Snapshots: TZIELD. FDA (2022) (regulatory); NIH: Drug delays type 1 diabetes in people at high risk (community).

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.

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