drugset / Trial / NCT00129259
Autoimmunity-blocking Antibody for Tolerance in Recently Diagnosed Type 1 Diabetes
Phase 2
Completed
83 enrolled
National Institute of Allergy and Infectious Diseases (NIAID)
Immune Tolerance Network (ITN) · collab
RandomizedParallel-groupSingle-blindTreatment
Summary
Anti-CD3 monoclonal antibody (a.k.a. hOKT3gamma1 \[Ala-Ala\],teplizumab, MGA031) is a humanized antibody that is commonly used to prevent organ rejection. The purpose of this study is determine whether anti-CD3 mAb treatment can halt the progression of newly diagnosed type 1 diabetes.
Timeline
- Start
- 2005-09
- Primary completion
- 2011-03
- Completion
- 2011-03
Outcome
Met primary endpoint
registry analysis (superiority or other test); Anti-CD3 mAb Plus Diabetes Standard of Care Treatment vs Diabetes Standard of Care Treatment; p = 0.002; ANCOVA NCT00129259 ↗
paper In the intent to treat analysis of the primary end point, patients treated with teplizumab had a reduced decline in C-peptide at 2 years PMID 23835333 ↗
Publications
- Background Herold KC, Gitelman SE, Masharani U, Hagopian W, Bisikirska B, Donaldson D, Rother K, Diamond B, Harlan DM, Bluestone JA. A single course of anti-CD3 monoclonal antibody hOKT3gamma1(Ala-Ala) results in improvement in C-peptide responses and clinical parameters for at least 2 years after onset of type 1 diabetes. Diabetes. 2005 Jun;54(6):1763-9. doi: 10.2337/diabetes.54.6.1763.
- Background Herold KC, Hagopian W, Auger JA, Poumian-Ruiz E, Taylor L, Donaldson D, Gitelman SE, Harlan DM, Xu D, Zivin RA, Bluestone JA. Anti-CD3 monoclonal antibody in new-onset type 1 diabetes mellitus. N Engl J Med. 2002 May 30;346(22):1692-8. doi: 10.1056/NEJMoa012864.
- Results Herold KC, Gitelman SE, Ehlers MR, Gottlieb PA, Greenbaum CJ, Hagopian W, Boyle KD, Keyes-Elstein L, Aggarwal S, Phippard D, Sayre PH, McNamara J, Bluestone JA; AbATE Study Team. Teplizumab (anti-CD3 mAb) treatment preserves C-peptide responses in patients with new-onset type 1 diabetes in a randomized controlled trial: metabolic and immunologic features at baseline identify a subgroup of responders. Diabetes. 2013 Nov;62(11):3766-74. doi: 10.2337/db13-0345. Epub 2013 Jul 8.
- Flammer ER, Higdon LE, Sanda S, Garrett TJ, Ismail HM. Baseline Serum Metabolites as Predictors of Teplizumab Response in Individuals with Type 1 Diabetes. medRxiv [Preprint]. 2025 Dec 23:2025.12.22.25342822. doi: 10.64898/2025.12.22.25342822.
- Ajmal N, Bogart MC, Khan P, Max-Harry IM, Healy AM, Nunemaker CS. Identifying Promising Immunomodulators for Type 1 Diabetes (T1D) and Islet Transplantation. J Diabetes Res. 2024 Dec 20;2024:5151171. doi: 10.1155/jdr/5151171. eCollection 2024.
- Boyle KD, Keyes-Elstein L, Ehlers MR, McNamara J, Rigby MR, Gitelman SE, Weiner LJ, Much KL, Herold KC. Two- and Four-Hour Tests Differ in Capture of C-Peptide Responses to a Mixed Meal in Type 1 Diabetes. Diabetes Care. 2016 Jun;39(6):e76-8. doi: 10.2337/dc15-2077. Epub 2016 Apr 13. No abstract available.
- Sherr JL, Ghazi T, Wurtz A, Rink L, Herold KC. Characterization of residual beta cell function in long-standing type 1 diabetes. Diabetes Metab Res Rev. 2014 Feb;30(2):154-62. doi: 10.1002/dmrr.2478.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Teplizumab | Monoclonal antibody | 826 ug/m2 | Intravenous |
| Subject | Teplizumab | Monoclonal antibody | 919 ug/m2 | Intravenous |