Registry for Stage 2 Type 1 Diabetes
- Registration Number
- NCT06481904
- Lead Sponsor
- Sanofi
- Brief 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 200
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
- 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
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Arm && Interventions
Group Intervention Description TZIELD group TZIELD (teplizumab-mzwv) Patients prior to the initiation of TZIELD treatment or initiated TZIELD treatment within 6 months to study enrollment
- Primary Outcome Measures
Name Time Method Number of adverse events (AE) in mothers, fetuses, and infants exposed to TZIELD during pregnancy From start of pregnancy to 12 months post-partum Developmental outcomes of the infant From birth of infant to 12 months Number of adverse events of special interests (AESI) Throughout the study, approximately 10 years Presence of AESIs including cytokine release syndrome (CRS), serious infections, hypersensitivity reactions, lymphoproliferative disorders, and malignancies
Number of serious adverse events (SAE) Throughout the study, approximately 10 years Number of maternal pregnancy-related events From start of pregnancy to 12 months post-partum
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (22)
University of Chicago Medical Center- Site Number : 8400017
🇺🇸Chicago, Illinois, United States
Riley Hospital for Children at IU Health- Site Number : 8400004
🇺🇸Indianapolis, Indiana, United States
Norton Healthcare- Site Number : 8400030
🇺🇸Louisville, Kentucky, United States
University of Michigan Health System - Ann Arbor- Site Number : 8400028
🇺🇸Ann Arbor, Michigan, United States
Texas Children's Hospital- Site Number : 8400002
🇺🇸Houston, Texas, United States
Cincinnati Children's Hospital Medical Center- Site Number : 8400024
🇺🇸Cincinnati, Ohio, United States
The Children's Hospital of Philadelphia- Site Number : 8400029
🇺🇸Philadelphia, Pennsylvania, United States
University of Texas - Southwestern Medical Center- Site Number : 8400003
🇺🇸Dallas, Texas, United States
University of Utah Health Care- Site Number : 8400019
🇺🇸Salt Lake City, Utah, United States
Johns Hopkins School of Medicine- Site Number : 8400031
🇺🇸Baltimore, Maryland, United States
Corewell Health- Site Number : 8400009
🇺🇸Grand Rapids, Michigan, United States
Mayo Clinic- Site Number : 8400010
🇺🇸Rochester, Minnesota, United States
Children's Mercy Adelle Hall Campus- Site Number : 8400014
🇺🇸Kansas City, Missouri, United States
Women and Children's Hospital of Buffalo- Site Number : 8400018
🇺🇸Buffalo, New York, United States
Ten's Medical PC- Site Number : 8400027
🇺🇸Staten Island, New York, United States
~SUNY Upstate Medical University- Site Number : 8400007
🇺🇸Syracuse, New York, United States
University of North Carolina at Chapel Hill- Site Number : 8400008
🇺🇸Chapel Hill, North Carolina, United States
Hospital of The University of Pennsylvania- Site Number : 8400021
🇺🇸Philadelphia, Pennsylvania, United States
Columbus Regional Healthcare- Site Number : 8400013
🇺🇸Columbus, Ohio, United States
Vanderbilt University Medical Center- Site Number : 8400023
🇺🇸Nashville, Tennessee, United States
The Ohio State University- Site Number : 8400032
🇺🇸Columbus, Ohio, United States
AM Diabetes & Endocrinology Center- Site Number : 8400012
🇺🇸Bartlett, Tennessee, United States