Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.
Registry for Stage 2 Type 1 Diabetes
NCT06481904 · View on ClinicalTrials.gov ↗
Study Summary
Stage 2 Type 1 Diabates (T1D) is an early stage of T1D characterized by dysglycemia but not yet leading to clinical symptoms. Progression of the disease to Stage 3 (clinical T1D), leads to overt hyperglycemia requiring eventually exogenous insulin. TZIELD® (teplizumab-mzwv) has been approved to delay onset of stage 3 T1D, by the United States (US) Food and Drug Administration (FDA) for adults and children aged 8 years and older with Stage 2 T1D. The purpose of this study is to collect general information on patients with stage 2 T1D and further information on the long-term effects of TZIELD® in patients with Stage 2 T1D, treated as per standard of care.
Conditions Studied
Interventions
- DRUG TZIELD (teplizumab-mzwv)
Study Locations (20)
Florida
- University of Florida Health- Site Number : 8400035 — Gainesville
- Nemours Children's Speciality Care- Jacksonville- Site Number : 8400006 — Jacksonville
- University of South Florida- Site Number : 8400022 — Tampa
Michigan
- University of Michigan Health System - Ann Arbor- Site Number : 8400028 — Ann Arbor
- Associated Endocrinologists, PC- Site Number : 8400039 — Farmington Hills
- Corewell Health - Grand Rapids - Michigan Street Northeast- Site Number : 8400009 — Grand Rapids
New York
- Women & Children's Hospital of Buffalo- Site Number : 8400018 — Buffalo
- Feinstein Institute for Medical Research (Northwell)- Site Number : 8400016 — Manhasset
- Ten's Medical PC- Site Number : 8400027 — Staten Island
California
- University of California Los Angeles Health- Site Number : 8400020 — Los Angeles
- University of California San Francisco - Mission Bay- Site Number : 8400005 — San Francisco
Colorado
- University of Colorado Hospital- Site Number : 8400026 — Aurora
Connecticut
- Yale University School of Medicine- Site Number : 8400025 — New Haven
Georgia
- Midtown Medical Center - Columbus- Site Number : 8400013 — Columbus
Illinois
- University of Chicago Medical Center- Site Number : 8400017 — Chicago
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 200 participants |
| Start Date | 2024-09-27 |
| Est. Completion | 2037-01-15 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT06481904
The ClinicalTrials.gov registry entry for NCT06481904 describes a study currently listed as recruiting. It is categorized as an unspecified phase, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 200 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Sanofi, which has 275 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.
The record links to 1 condition, with Type 1 Diabetes appearing as the primary indexed condition, and to 1 intervention — of which TZIELD (teplizumab-mzwv) is the first listed. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.
Geographic footprint matters for practical reasons: NCT06481904 reports 20 study locations spanning 13 distinct geographic areas — top geographies include Florida, Michigan, New York. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.
Frequently Asked Questions
What is clinical trial NCT06481904 about?
NCT06481904 is a clinical study titled "Registry for Stage 2 Type 1 Diabetes". Stage 2 Type 1 Diabates (T1D) is an early stage of T1D characterized by dysglycemia but not yet leading to clinical symptoms. Progression of the disease to Stage 3 (clinical T1D), leads to overt hyperglycemia requiring eventually exogenous insulin. TZIELD® (teplizumab-mzwv) has been approved to del...
What is the current status of trial NCT06481904?
This trial is currently recruiting. The enrollment target is 200 participants. The study started on 2024-09-27. Estimated completion is 2037-01-15.
What conditions does trial NCT06481904 study?
This clinical trial studies the following conditions: Type 1 Diabetes. These conditions were identified from the trial registry and reflect the primary focus areas of the research.
What interventions are being tested in trial NCT06481904?
The interventions under investigation include: TZIELD (teplizumab-mzwv) (DRUG). Each intervention is being evaluated for safety and efficacy as part of this clinical study.
Who is sponsoring clinical trial NCT06481904?
This trial is sponsored by Sanofi, which has 275 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.
Where is trial NCT06481904 being conducted?
This trial has 20 study locations across California, Colorado, Connecticut, Florida, Georgia. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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