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NCT06892002: TEPLI-REAL
Description of Patients With Type 1 Diabetes Treated With Teplizumab
trial testing Teplizumab in Type 1 Diabetes in 110 participants. Completed in 5 August 2025.
5 August 2025
Quick facts
| Lead sponsor | Sanofi |
|---|---|
| Status | Completed |
| Study type | OBSERVATIONAL |
| Enrollment | 110 |
| Start date | 11 February 2025 |
| Primary completion | 5 August 2025 |
| Estimated completion | 5 August 2025 |
| Sites | 27 locations across United States, Israel |
Drugs / interventions tested
- Teplizumab (TEPLIZUMAB) — full drug profile →
Conditions studied
- Type 1 Diabetes — all drugs for Type 1 Diabetes →
Sponsor
Sanofi — full company profile →
Who can join
Eligibility, any sex, with Type 1 Diabetes. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
Type 1 diabetes mellitus (T1D) is a chronic autoimmune disease caused by the destruction of pancreatic β cells. T1D pathogenesis progresses through several stages: Stage 1 T1D includes the presence of β cell autoimmunity and thus presence of islet autoantibodies, without the presence of dysglycemia and symptoms. Stage 2 T1D includes the presence of islet autoantibodies and dysglycemia, also with no symptoms. Stage 3 T1D includes presence of islet autoantibodies, overt hyperglycemia, and symptoms; most patients with Stage 3 T1D meet standard diagnostic criteria for diabetes and require insulin treatment. Teplizumab has been shown to delay progression to Stage 3 in participants at Stage 2 in a Phase 2 clinical trial, leading to subsequent approval in the United States of America (USA). Patients outside of the USA are able to receive the treatment through Pre-Registration Import Licenses and Managed Access Programs. The current study will collect data on the use of teplizumab in routine care, to better understand which patients received teplizumab and how these patients were managed after they received the treatment.
Publications & conference data
1 peer-reviewed publication reference this trial (live from Europe PMC):
-
Redosing of anti-CD3 antibodies in NOD mice with new-onset diabetes does not alter the effect of a single treatment course.
Wouters A, Lemaitre P, Degroote L, Viaene M, et al · · 2026 · PMID 41261242 · DOI 10.1007/s00125-025-06604-2
Verify or expand the search:
- PubMed search for NCT06892002
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
Other trials of Teplizumab
Trials testing the same drug.
- NCT07216391 — Platform Trial to Delay Stage 3 Diabetes: Comparing Teplizumab With ATG · Phase 2 · not yet recruiting
- NCT07360080 — Long-Term Outcomes of Teplizumab in Routine Clinical Care · recruiting
- NCT07457580 — Real-World Study of Patients With Type 1 Diabetes Treated With Teplizumab as Part of Managed Access Programs (MAPs) · recruiting
- NCT07260110 — A Longitudinal, Observational Study Comparing Real-World Experiences of Teplizumab-Treated and Untreated Participants Wi · recruiting
- NCT07088068 — A Study to Investigate Efficacy and Safety of Teplizumab Compared With Placebo in Participants 1 to 25 Years of Age With · Phase 3 · recruiting
Other recruiting trials for Type 1 Diabetes
Currently open trials in the same condition.
- NCT07061574 — A Randomized Phase 1/2 Trial of Low Dose Anti-thymocyte Globulin (ATG) With Subsequent Adalimumab or Verapamil in New On · Phase 1, PHASE2 · recruiting
- NCT07360080 — Long-Term Outcomes of Teplizumab in Routine Clinical Care · recruiting
- NCT07457580 — Real-World Study of Patients With Type 1 Diabetes Treated With Teplizumab as Part of Managed Access Programs (MAPs) · recruiting
- NCT07212179 — Safety and Feasibility of a Self-Learning Bolus Calculator With Simplified Meal Announcement in Adolescents With Type 1 · NA · recruiting
- NCT07287943 — To Study the Efficacy and Safety of Medtronic 780G Insulin Pump in People With Gastroparesis and Type 1 Diabetes. · NA · recruiting
Other Sanofi trials
Trials by the same sponsor.
- NCT07282795 — Post-marketing Surveillance Study for the Safety of Efluelda® Pre-filled Syringe · not yet recruiting
- NCT06694025 — Post-marketing Surveillance Study for the Safety of Efluelda Tetra Pre-filled Syringe. · not yet recruiting
- NCT07222189 — A Study to Investigate the Long-term Safety, Tolerability and Efficacy of Balinatunfib in Participants With Crohn's Dise · Phase 2 · not yet recruiting
- NCT07484230 — A Phase 3 Study to Assess the Efficacy, Safety, and Tolerability of Itepekimab (Anti-IL-33 mAb) in Adult Japanese Partic · Phase 3 · not yet recruiting
- NCT07547436 — A Study to Access Activity and Safety With SAR445399 Compared With Placebo in Participants Aged 18 to 80 Years of Age Wi · Phase 2 · recruiting
Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT06892002 (US National Library of Medicine, public domain)
- Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by Sanofi
- Last refreshed: 15 August 2025
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT06892002.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing