Registry for Stage 2 Type 1 Diabetes

a study on Diabetes Diabetes Type 1

Summary

Location
at San Francisco, California and other locations
Dates
study started
study ends around

Description

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.

Official Title

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

Keywords

Type 1 Diabetes, Diabetes Mellitus, Type 1 Diabetes Mellitus, TZIELD (teplizumab-mzwv)

Eligibility

You can join if…

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

You CAN'T join if...

  • 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

Locations

  • UCSF - Mission Bay- Site Number : 8400005 accepting new patients
    San Francisco California 94158 United States
  • University of Utah Health Care- Site Number : 8400019 accepting new patients
    Salt Lake City Utah 84132-0001 United States

Details

Status
accepting new patients
Start Date
Completion Date
(estimated)
Sponsor
Sanofi
ID
NCT06481904
Study Type
Observational
Participants
Expecting 200 study participants
Last Updated
Contact us about this trial