Registry for Stage 2 Type 1 Diabetes

Part of paid clinical trials in Los Angeles, California.

Sponsor
Sanofi
Study ID
NCT06481904
Status
Recruiting
Apply to this trial

Conditions

Eligibility Criteria

Sex
ALL
Age
N/A - N/A
Healthy Volunteers
Not accepted

Interventions

  • TZIELD (teplizumab-mzwv) — DRUG
    This study will not administer any treatment, only observe the treatment as prescribed in real-world clinical practice.

Study Details

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.

Key Dates

Start date
Sep 27, 2024
Status verified
Apr 2026
Primary completion
Jan 15, 2037
Completion
Jan 15, 2037

Study Design

Enrollment
200 participants (estimated)

Arms

  • Arm: TZIELD group
    Patients prior to the initiation of TZIELD treatment or initiated TZIELD treatment within 6 months to study enrollment
  • Arm: Comparator group
    Patients not planned to be treated

Primary Outcome Measure

Number of adverse events of special interests (AESI) [ Time Frame: Throughout the study, approximately 10 years ]

Central Contacts

  • Trial Transparency email recommended (Toll free for US & Canada)
    800-633-1610
    [email protected]

Locations (37)

FacilityCityStateZIPSite coordinators
University of California Los Angeles Health- Site Number : 8400020Los AngelesCalifornia90095-
University of California San Francisco - Mission Bay- Site Number : 8400005San FranciscoCalifornia94158-
University of Colorado Hospital- Site Number : 8400026AuroraColorado80045-
Yale University School of Medicine- Site Number : 8400025New HavenConnecticut06510-
University of Florida Health- Site Number : 8400035GainesvilleFlorida32610-
Nemours Children's Speciality Care- Jacksonville- Site Number : 8400006JacksonvilleFlorida32207-
Nicklaus Children's Hospital - Miami - Southwest 62nd Avenue- Site Number : 8400034MiamiFlorida33155-
University of Miami Miller School of Medicine- Site Number : 8400037MiamiFlorida33136-
University of South Florida- Site Number : 8400022TampaFlorida33612-
Midtown Medical Center - Columbus- Site Number : 8400013ColumbusGeorgia31901-
University of Chicago Medical Center- Site Number : 8400017ChicagoIllinois60637-
Indiana University Health Riley Hospital for Children- Site Number : 8400004IndianapolisIndiana46202-
Norton Brownsboro Hospital- Site Number : 8400030LouisvilleKentucky40241-
Johns Hopkins School of Medicine- Site Number : 8400031BaltimoreMaryland21205-
University of Michigan Health System - Ann Arbor- Site Number : 8400028Ann ArborMichigan48109-
Associated Endocrinologists, PC- Site Number : 8400039Farmington HillsMichigan48334-
Corewell Health - Grand Rapids - Michigan Street Northeast- Site Number : 8400009Grand RapidsMichigan49503-
Mayo Clinic- Site Number : 8400010RochesterMinnesota55902-
Children's Mercy Adelle Hall Campus- Site Number : 8400014Kansas CityMissouri64108-
Women & Children's Hospital of Buffalo- Site Number : 8400018BuffaloNew York14222-
Feinstein Institute for Medical Research (Northwell)- Site Number : 8400016ManhassetNew York11030-
Ten's Medical PC- Site Number : 8400027Staten IslandNew York10306-
SUNY Upstate Medical University - Syracuse- Site Number : 8400007SyracuseNew York13210-
UNC Children's Hospital- Site Number : 8400008Chapel HillNorth Carolina27514-
Cincinnati Children's Hospital Medical Center- Site Number : 8400024CincinnatiOhio45229-
Rainbow Babies And Children's Hospital- Site Number : 8400011ClevelandOhio44106-
The Ohio State University- Site Number : 8400032ColumbusOhio43210-
Hospital of The University of Pennsylvania- Site Number : 8400021PhiladelphiaPennsylvania19104-
The Children's Hospital of Philadelphia- Site Number : 8400029PhiladelphiaPennsylvania19104-
AM Diabetes & Endocrinology Center- Site Number : 8400012BartlettTennessee38133-
Vanderbilt University Medical Center- Site Number : 8400023NashvilleTennessee37232-
Texas Diabetes & Endocrinology - Austin - North Mopac Expressway- Site Number : 8400040AustinTexas78731-
University of Texas - Southwestern Medical Center- Site Number : 8400003DallasTexas75390-
Cook Children's- Site Number : 8400038Fort WorthTexas76104-
Texas Children's Hospital- Site Number : 8400002HoustonTexas77030-
University of Utah Health Hospital- Site Number : 8400019Salt Lake CityUtah84132-
United BioSource Corporation- Site Number : 8400001MorgantownWest Virginia26505-

Find similar trials in Los Angeles, CA

By condition
Type 1 diabetes
By specialty
Endocrinology
By research site
University of California Los Angeles Health· Los Angeles, CAUniversity of California San Francisco - Mission Bay· San Francisco, CAUniversity of Colorado Hospital· Aurora, COYale University School of Medicine· New Haven, CTUniversity of Florida Health· Gainesville, FLNemours Children's Speciality Care- Jacksonville· Jacksonville, FL

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