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NCT06481904 · ClinicalTrials.gov registry record
Registry for Stage 2 Type 1 Diabetes
A clinical trial of Type 1 Diabetes, sponsored by Sanofi.
- Recruiting
- Registry status
- 200
- Enrollment target
- 20
- Study locations
NCT06481904: Recruiting study of Type 1 Diabetes, sponsored by Sanofi.
NCT06481904 is a study of Type 1 Diabetes that is actively recruiting participants, run by Sanofi. The registered enrollment target is 200 participants, below the 766-participant average among 198 other Type 1 Diabetes trials with a reported enrollment target (74% lower). The trial reports 20 study locations across 13 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT06481904, a study of Type 1 Diabetes, is actively recruiting participants, sponsored by Sanofi.
- RECRUITING
- Registry status
- 200 participants
- Enrollment target
- 20
- Study locations
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.
Primary Outcome
Presence of AESIs including cytokine release syndrome (CRS), serious infections, hypersensitivity reactions, lymphoproliferative disorders, and malignancies
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 |
What NCT06481904 shows while recruiting
NCT06481904 is an observational study that tracks outcomes without assigning an intervention. The registered 200 participants enrollment target is mid-sized for trials with a published cap, below the 766-participant average among 198 other Type 1 Diabetes trials with a reported enrollment target (74% lower).
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.
NCT06481904 names 20 study sites across 13 states, led by Florida, Michigan, New York.
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.
What interventions are being tested in trial NCT06481904?
The interventions under investigation include: TZIELD (teplizumab-mzwv) (DRUG).
Who is sponsoring clinical trial NCT06481904?
This trial is sponsored by Sanofi, which has 713 total clinical trials registered on ClinicalTrials.gov.
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.
Learn More About Clinical Trials
Similar trials for Type 1 Diabetes
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT06481904's enrollment target sits among peer trials
200 29th of 198 higher than 169 of 198 other Type 1 Diabetes trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Type 1 Diabetes trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
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