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RECRUITINGOBSERVATIONAL

Registry for Stage 2 Type 1 Diabetes

An Observational, Long-term Safety Study of TZIELD® (Teplizumab-mzwv) in Patients With Stage 2 Type 1 Diabetes

Important: This information is not medical advice. Talk to your doctor about whether a clinical trial is right for you.

About This Trial

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 May Be Eligible (Plain English)

Who May Qualify: 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 willing to sign a consent form/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 willing to sign a consent form/assent as applicable for the age of the patient Who Should NOT Join This Trial: - 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. Always talk to your doctor about whether this trial is right for you.

Original Eligibility Criteria

View original clinical language
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.

Treatments Being Tested

DRUG

TZIELD (teplizumab-mzwv)

This study will not administer any treatment, only observe the treatment as prescribed in real-world clinical practice.

Locations (20)

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 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