Registry for Stage 2 Type 1 Diabetes

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

Recruiting
All
Phase N/A
200 participants needed
34 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

The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.

This study investigates Stage 2 Type 1 Diabetes, focusing on the early stage of the disease where blood sugar levels are abnormal. The purpose of this study is to collect information on patients with Stage 2 Type 1 Diabetes and observe the long-term effects of an investigational medication. Participants will be involved in the study for a period that is not specified in the provided information.

Participants will be divided into two study arms: those receiving the investigational medication and those not receiving it. The study will involve observing and collecting data about their health and treatment outcomes. This will help in understanding how the investigational medication affects the progression of the disease.

  • Who can participate: Participants must be diagnosed with Stage 2 Type 1 Diabetes and be located in the US. They must either be planning to start or have started treatment with the investigational medication within the last 6 months, or not be receiving the medication at all. Written consent is required.
  • Study details: Participants will be observed to collect data about their health and any treatments they receive. This will help understand the effects of the investigational medication on the disease over time.
Updated on 12 Feb 2026. Study ID: NCT06481904

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