Registry for Stage 2 Type 1 Diabetes
Recruiting · NCT06481904 · Observational (researchers observe without assigning treatment) · Lead sponsor: Sanofi
View the official record on ClinicalTrials.gov →Interventions studied
TZIELD (teplizumab-mzwv)
What this trial is about
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.
Who can take part
Age range
No age limits stated
Sex
All (male and female)
Healthy volunteers
No - a diagnosis or condition is required
Phase
Not specified
Study type
Observational (researchers observe without assigning treatment)
Inclusion criteria
- 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
Exclusion criteria
- 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
37 locations listed across 20 US states.
- University of California Los Angeles Health- Site Number : 8400020 - Los Angeles, California, United States
- University of California San Francisco - Mission Bay- Site Number : 8400005 - San Francisco, California, United States
- University of Colorado Hospital- Site Number : 8400026 - Aurora, Colorado, United States
- Yale University School of Medicine- Site Number : 8400025 - New Haven, Connecticut, United States
- University of Florida Health- Site Number : 8400035 - Gainesville, Florida, United States
- Nemours Children's Speciality Care- Jacksonville- Site Number : 8400006 - Jacksonville, Florida, United States
- University of Miami Miller School of Medicine- Site Number : 8400037 - Miami, Florida, United States
- Nicklaus Children's Hospital - Miami - Southwest 62nd Avenue- Site Number : 8400034 - Miami, Florida, United States
- University of South Florida- Site Number : 8400022 - Tampa, Florida, United States
- Midtown Medical Center - Columbus- Site Number : 8400013 - Columbus, Georgia, United States
- University of Chicago Medical Center- Site Number : 8400017 - Chicago, Illinois, United States
- Indiana University Health Riley Hospital for Children- Site Number : 8400004 - Indianapolis, Indiana, United States
- Norton Brownsboro Hospital- Site Number : 8400030 - Louisville, Kentucky, United States
- Johns Hopkins School of Medicine- Site Number : 8400031 - Baltimore, Maryland, United States
- University of Michigan Health System - Ann Arbor- Site Number : 8400028 - Ann Arbor, Michigan, United States
- Associated Endocrinologists, PC- Site Number : 8400039 - Farmington Hills, Michigan, United States
- Corewell Health - Grand Rapids - Michigan Street Northeast- 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 & Children's Hospital of Buffalo- Site Number : 8400018 - Buffalo, New York, United States
- Feinstein Institute for Medical Research (Northwell)- Site Number : 8400016 - Manhasset, New York, United States
- Ten's Medical PC- Site Number : 8400027 - Staten Island, New York, United States
- SUNY Upstate Medical University - Syracuse- Site Number : 8400007 - Syracuse, New York, United States
- UNC Children's Hospital- Site Number : 8400008 - Chapel Hill, North Carolina, United States
- Cincinnati Children's Hospital Medical Center- Site Number : 8400024 - Cincinnati, Ohio, United States
- Rainbow Babies And Children's Hospital- Site Number : 8400011 - Cleveland, Ohio, United States
- The Ohio State University- Site Number : 8400032 - Columbus, Ohio, United States
- Hospital of The University of Pennsylvania- Site Number : 8400021 - Philadelphia, Pennsylvania, United States
- The Children's Hospital of Philadelphia- Site Number : 8400029 - Philadelphia, Pennsylvania, United States
- AM Diabetes & Endocrinology Center- Site Number : 8400012 - Bartlett, Tennessee, United States
- Vanderbilt University Medical Center- Site Number : 8400023 - Nashville, Tennessee, United States
- Texas Diabetes & Endocrinology - Austin - North Mopac Expressway- Site Number : 8400040 - Austin, Texas, United States
- University of Texas - Southwestern Medical Center- Site Number : 8400003 - Dallas, Texas, United States
- Cook Children's- Site Number : 8400038 - Fort Worth, Texas, United States
- Texas Children's Hospital- Site Number : 8400002 - Houston, Texas, United States
- University of Utah Health Hospital- Site Number : 8400019 - Salt Lake City, Utah, United States
- United BioSource Corporation- Site Number : 8400001 - Morgantown, West Virginia, United States