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Registry for Stage 2 Type 1 Diabetes

NCT06481904

RecruitingN/A

Sponsor: Sanofi

Conditions: Type 1 Diabetes

Interventions: TZIELD (teplizumab-mzwv)

Countries: United States

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.

Eligibility overview

Sex: ALL

Healthy volunteers: No

Study type: OBSERVATIONAL

Eligibility criteria

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.

Locations (37)

Los Angeles, California, United States
San Francisco, California, United States
Aurora, Colorado, United States
New Haven, Connecticut, United States
Gainesville, Florida, United States
Jacksonville, Florida, United States
Miami, Florida, United States
Miami, Florida, United States
Tampa, Florida, United States
Columbus, Georgia, United States
Chicago, Illinois, United States
Indianapolis, Indiana, United States
Louisville, Kentucky, United States
Baltimore, Maryland, United States
Ann Arbor, Michigan, United States
Farmington Hills, Michigan, United States
Grand Rapids, Michigan, United States
Rochester, Minnesota, United States
Kansas City, Missouri, United States
Buffalo, New York, United States
Manhasset, New York, United States
Staten Island, New York, United States
Syracuse, New York, United States
Chapel Hill, North Carolina, United States
Cincinnati, Ohio, United States
Cleveland, Ohio, United States
Columbus, Ohio, United States
Philadelphia, Pennsylvania, United States
Philadelphia, Pennsylvania, United States
Bartlett, Tennessee, United States
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