Clinical trial NCT06481904: Registry for Stage 2 Type 1 Diabetes
Official title: An Observational, Long-term Safety Study of TZIELD® (Teplizumab-mzwv) in Patients With Stage 2 Type 1 Diabetes
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Type 1 Diabetes
Lead sponsor: Sanofi
Sponsor class: INDUSTRY
First posted: 2024-07-01
Enrollment: 200
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patients in the US diagnosed with Stage 2 Type 1 Diabetes

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.


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

Primary outcomes:
measure: Number of adverse events of special interests (AESI)
timeFrame: Throughout the study, approximately 10 years
measure: Number of serious adverse events (SAE)
timeFrame: Throughout the study, approximately 10 years
measure: Number of adverse events (AE) in mothers, fetuses, and infants exposed to TZIELD during pregnancy
timeFrame: From start of pregnancy to 12 months post-partum
measure: Number of maternal pregnancy-related events
timeFrame: From start of pregnancy to 12 months post-partum
measure: Developmental outcomes of the infant
timeFrame: From birth of infant to 12 months
Secondary outcomes:
Other outcomes:
Locations:
city: Chicago
country: United States
facility: University of Chicago Medical Center- Site Number : 8400017
state: Illinois
city: Indianapolis
country: United States
facility: Riley Hospital for Children at IU Health- Site Number : 8400004
state: Indiana
city: Louisville
country: United States
facility: Norton Healthcare- Site Number : 8400030
state: Kentucky
city: Baltimore
country: United States
facility: Johns Hopkins School of Medicine- Site Number : 8400031
state: Maryland
city: Ann Arbor
country: United States
facility: University of Michigan Health System - Ann Arbor- Site Number : 8400028
state: Michigan
city: Grand Rapids
country: United States
facility: Corewell Health- Site Number : 8400009
state: Michigan
city: Rochester
country: United States
facility: Mayo Clinic- Site Number : 8400010
state: Minnesota
city: Kansas City
country: United States
facility: Children's Mercy Adelle Hall Campus- Site Number : 8400014
state: Missouri
city: Buffalo
country: United States
facility: Women and Children's Hospital of Buffalo- Site Number : 8400018
state: New York
city: Staten Island
country: United States
facility: Ten's Medical PC- Site Number : 8400027
state: New York
city: Syracuse
country: United States
facility: ~SUNY Upstate Medical University- Site Number : 8400007
state: New York
city: Chapel Hill
country: United States
facility: University of North Carolina at Chapel Hill- Site Number : 8400008
state: North Carolina
city: Cincinnati
country: United States
facility: Cincinnati Children's Hospital Medical Center- Site Number : 8400024
state: Ohio
city: Columbus
country: United States
facility: Columbus Regional Healthcare- Site Number : 8400013
state: Ohio
city: Columbus
country: United States
facility: The Ohio State University- Site Number : 8400032
state: Ohio
city: Philadelphia
country: United States
facility: Hospital of The University of Pennsylvania- Site Number : 8400021
state: Pennsylvania
city: Philadelphia
country: United States
facility: The Children's Hospital of Philadelphia- Site Number : 8400029
state: Pennsylvania
city: Bartlett
country: United States
facility: AM Diabetes & Endocrinology Center- Site Number : 8400012
state: Tennessee
city: Nashville
country: United States
facility: Vanderbilt University Medical Center- Site Number : 8400023
state: Tennessee
city: Dallas
country: United States
facility: University of Texas - Southwestern Medical Center- Site Number : 8400003
state: Texas
city: Houston
country: United States
facility: Texas Children's Hospital- Site Number : 8400002
state: Texas
city: Salt Lake City
country: United States
facility: University of Utah Health Care- Site Number : 8400019
state: Utah
Study officials:
affiliation: Sanofi
name: Clinical Sciences & Operations
role: STUDY_DIRECTOR
References: