16 September 2026 editorial review · Trial
Protégé: Anti-CD3 (teplizumab) 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 →Baseline trial evidence review: M–S
Outcome: Corrected direct item relationships; shared class or background is insufficient.
Registry: NCT00385697. Endpoint reviewed: Number of Subjects in Segment 2 With Both a Total Daily Insulin Dose of Less Than 0.5 U/kg/Day and Hemoglobin A1c (HbA1c) Level of Less Than 6.5%. (52 weeks after randomization); Number of Subjects in Segment 1 With Both a Total Daily Insulin Dose of Less Than 0.5 U/kg/Day and Hemoglobin A1c (HbA1c) Level of Less Than 6.5%. (52 weeks after first dose); Mean HbA1c Change From Baseline in Segment 2 (52 weeks after randomization); Mean HbA1c Change From Baseline in Segment 1 (52 weeks after first dose). Eligibility reviewed: Age 8 Years to 35 Years; diagnosis/stage, prior therapy and key biomarker criteria compared with site summary. Full exclusions remain in the registry. Additional source access: Teplizumab for treatment of type 1 diabetes (Protégé study): 1-year results from a randomised, placebo-controlled trial.; Teplizumab preserves C-peptide in recent-onset type 1 diabetes: two-year results from the randomized, placebo-controlled Protégé trial..