Registry for Stage 2 Type 1 Diabetes

Study on Long-term Effects of Investigational Medication in Early Stage Type 1 Diabetes

Recruiting
All
Phase N/A
200 participants needed
22 Locations

Study Overview

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

You may be eligible for this study if you meet the following criteria:

  • Conditions: Type 1 Diabetes
  • Gender: All

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

Updated on 01 Apr 2025. Study ID: NCT06481904

This study investigates the long-term effects of an investigational medication in patients with Stage 2 Type 1 Diabetes (T1D). Stage 2 T1D is an early stage of the disease where there are changes in blood sugar levels, but no clinical symptoms are present yet. If the disease progresses to Stage 3, it leads to high blood sugar levels that require insulin treatment. The investigational medication aims to delay the onset of Stage 3 T1D.

Participants in the study will be divided into two study arms: one arm will include patients who are treated with the investigational medication as part of their standard care, and the other arm will include patients who are not receiving this treatment. The study will collect information on the patients' health and the effects of the treatment over time. All participants will need to provide written consent to take part in the study.

  • Who can participate: Adults and children aged 8 years and older diagnosed with Stage 2 Type 1 Diabetes in the US can participate. Participants must plan to start or have started the investigational treatment within the last 6 months, or not be receiving the treatment at all.
  • Study details: Participants will receive the investigational medication as part of their standard care or not receive it, depending on their study arm. The study will monitor patients' health and collect data on the effects of the medication over time.

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