Registry for Stage 2 Type 1 Diabetes
Recruiting now
Conditions studied: Type 1 Diabetes
In brief
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.
Key facts
- Study ID
- NCT06481904
- Run by
- Sanofi
- People needed
- 200
- Starts
- 2024-09-27
- Expected to finish
- 2037-01-15
- Last updated by the study team
- 2026-04-13
Who can join
Age: any. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- TZIELD-Exposed Cohort
- Patients in the US diagnosed with Stage 2 T1D who are planned to initiate TZIELD treatment according to the currently approved label or who have initiated TZIELD treatment within 6 months prior to enrollment:
- Day 1: 65 mcg/m2
- Day 2: 125 mcg/m2
- Day 3: 250 mcg/m2
- Day 4: 500 mcg/m2
- Days 5 through 14: 1,030 mcg/m2 per day
- Cumulative dose is approximately 11,240 mcg/m2
- Appropriate written informed consent/assent as applicable for the age of the patient
- TZIELD-Unexposed Cohort
- Patients in the US diagnosed with Stage 2 T1D but who are not treated with TZIELD
- Appropriate written informed consent/assent as applicable for the age of the patient
You may not qualify if…
- Patients who initiated TZIELD treatment more than 6 months prior to enrollment
- Patients who had participated in a previous clinical trial for TZIELD
- Patients in an ongoing clinical trial of an investigational product or who had ended participation within 6 months prior to study enrollment; patients participating in other observational studies may be enrolled
- The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.
Where it is running
- University of California Los Angeles Health- Site Number : 8400020 — Los Angeles, California, United States (enrolling)
- University of California San Francisco - Mission Bay- Site Number : 8400005 — San Francisco, California, United States (enrolling)
- University of Colorado Hospital- Site Number : 8400026 — Aurora, Colorado, United States (enrolling)
- Yale University School of Medicine- Site Number : 8400025 — New Haven, Connecticut, United States (enrolling)
- University of Florida Health- Site Number : 8400035 — Gainesville, Florida, United States (enrolling)
- Nemours Children's Speciality Care- Jacksonville- Site Number : 8400006 — Jacksonville, Florida, United States (enrolling)
- University of Miami Miller School of Medicine- Site Number : 8400037 — Miami, Florida, United States (enrolling)
- Nicklaus Children's Hospital - Miami - Southwest 62nd Avenue- Site Number : 8400034 — Miami, Florida, United States (enrolling)
- University of South Florida- Site Number : 8400022 — Tampa, Florida, United States (enrolling)
- Midtown Medical Center - Columbus- Site Number : 8400013 — Columbus, Georgia, United States (enrolling)
- University of Chicago Medical Center- Site Number : 8400017 — Chicago, Illinois, United States (enrolling)
- Indiana University Health Riley Hospital for Children- Site Number : 8400004 — Indianapolis, Indiana, United States (enrolling)
- Norton Brownsboro Hospital- Site Number : 8400030 — Louisville, Kentucky, United States (enrolling)
- Johns Hopkins School of Medicine- Site Number : 8400031 — Baltimore, Maryland, United States (enrolling)
- University of Michigan Health System - Ann Arbor- Site Number : 8400028 — Ann Arbor, Michigan, United States (enrolling)
- Associated Endocrinologists, PC- Site Number : 8400039 — Farmington Hills, Michigan, United States (enrolling)
- Corewell Health - Grand Rapids - Michigan Street Northeast- Site Number : 8400009 — Grand Rapids, Michigan, United States (enrolling)
- Mayo Clinic- Site Number : 8400010 — Rochester, Minnesota, United States (enrolling)
- Children's Mercy Adelle Hall Campus- Site Number : 8400014 — Kansas City, Missouri, United States (enrolling)
- Women & Children's Hospital of Buffalo- Site Number : 8400018 — Buffalo, New York, United States (enrolling)
- Feinstein Institute for Medical Research (Northwell)- Site Number : 8400016 — Manhasset, New York, United States (enrolling)
- Ten's Medical PC- Site Number : 8400027 — Staten Island, New York, United States (enrolling)
- SUNY Upstate Medical University - Syracuse- Site Number : 8400007 — Syracuse, New York, United States (enrolling)
- UNC Children's Hospital- Site Number : 8400008 — Chapel Hill, North Carolina, United States (enrolling)
- Cincinnati Children's Hospital Medical Center- Site Number : 8400024 — Cincinnati, Ohio, United States (enrolling)
Full record on ClinicalTrials.gov
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