Recent-Onset Type 1 Diabetes Trial Evaluating Efficacy and Safety of Teplizumab
Summary
The purpose of this study is to determine whether teplizumab slows the loss of β cells and preserves β cell function in children and adolescent 8-17 years old who have been diagnosed with T1D in the previous 6 weeks.. Subjects will receive two courses of either teplizumab or placebo treatment 6 months apart.
Timeline
- Start
- 2019-04-05
- Primary completion
- 2023-05-01
- Completion
- 2023-05-01
Outcome
Met primary endpoint
registry analysis (superiority test); Placebo vs Teplizumab; p <0.001; Mean Difference (Net) 0.1253 (95% CI 0.0852 to 0.1653); ANCOVA; NCT03875729 ↗
paper Patients treated with teplizumab (217 patients) had significantly higher stimulated C-peptide levels than patients receiving placebo (111 patients) at week 78 PMID 37861217 ↗
paper showed benefit with respect to the primary end point of preservation of β-cell function PMID 37861217 ↗
release “Sanofi S.A. (Sanofi) reported that the PROTECT placebo-controlled study investigating TZIELD in patients with newly diagnosed stage 3 Type 1 diabetes met its primary endpoint” macrogenics.com ↗
release “The sBLA is supported by the results from the PROTECT phase 3 study , which met its primary endpoint” sanofi.com ↗
Publications
- Results Ramos EL, Dayan CM, Chatenoud L, Sumnik Z, Simmons KM, Szypowska A, Gitelman SE, Knecht LA, Niemoeller E, Tian W, Herold KC; PROTECT Study Investigators. Teplizumab and beta-Cell Function in Newly Diagnosed Type 1 Diabetes. N Engl J Med. 2023 Dec 7;389(23):2151-2161. doi: 10.1056/NEJMoa2308743. Epub 2023 Oct 18.
- 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.
- Novograd J, Frishman WH. Teplizumab Therapy to Delay the Onset of Type 1 Diabetes. Cardiol Rev. 2024 Nov-Dec 01;32(6):572-576. doi: 10.1097/CRD.0000000000000563. Epub 2023 May 9.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Teplizumab | Monoclonal antibody | 850 ug/m2 | Intravenous |