16 September 2026 editorial review · Item
Teplizumab for new-onset T1D (Tzield): 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 item evidence page →Preventing and curing evidence review — 16 September 2026
- Disposition: corrected/updated. Current item
lastReviewed: 2026-09-16. - Claim check: June label risks and original PROTECT secondary-null results remain. Added the 10 September 2026 pre-specified per-protocol analysis: 275 selected participants, TIR +6.17 percentage points with nominal P<.05; it is not a new trial or independent replication. No score upgrade. Retained the distinction between DCCT C-peptide/DKA association and demonstrated drug benefit.
- Registry NCT03875729: COMPLETED; updated 2024-04-24; enrollment 328 (ACTUAL); primary completion 2023-05-01 (ACTUAL); results posted.
- Registry NCT00385697: COMPLETED; updated 2023-12-05; enrollment 554 (ACTUAL); primary completion 2010-06 (ACTUAL); results posted.
- Registry NCT07088068: RECRUITING; updated 2026-09-14; enrollment 723 (ESTIMATED); primary completion 2028-06-06 (ESTIMATED); results not posted in retrieved record.
- Primary publication/regulatory sources checked or consulted: s00125-026-06849-5; tzield.pdf; NEJMoa2308743; NEJMoa012864; diabetes.54.6.1763; S0140-6736%2811%2960931-8; db13-0345; fda-approves-drug-pediatric-stage-3-type-i-diabetes; dc26-0220; NEJMoa2308743; diabetes.54.6.1763; NEJMoa012864; db13-0345; S0140-6736%2811%2960931-8; dc26-0220.
- Programme/sponsor/conference source boundary: Sanofi's Tzield approved in the US as the first disease-modifying therapy for patients recently diagnosed with stage 3 type 1 diabetes (manufacturer); Sanofi's Teizeild approved in the EU for patients with stage 2 type 1 diabetes (manufacturer).