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Registry for Stage 2 Type 1 Diabetes

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

Who can join

As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.

Age
No age limits stated
Sex
All sexes
Healthy volunteers
Not accepted
Compensation
Not stated

Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.

What to expect

No one can promise a trial will help you personally — that is what the research is trying to find out.

What participation involves

Not stated in the study description — ask the study team about visits and procedures.

Compensation
Not stated
  • Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
  • Participants are monitored closely by the research team throughout the study.
  • Some participants may receive access to an investigational treatment, which is still being studied.
  • Your participation helps researchers learn whether this approach could help future patients.

About this study

In plain language

This study collects information about people with stage 2 type 1 diabetes, when blood sugar is not normal but symptoms have not started. It also tracks the long-term effects of TZIELD given as part of usual care. The study includes people in the US who receive TZIELD and those who do not.

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.

Compensation is read from the study's own description and may be missing — always confirm with the study team.

Eligibility

Who can join

  • Live in the US and have stage 2 type 1 diabetes.
  • For the TZIELD group: plan to start TZIELD under its approved use and dose schedule, or have started it within 6 months before joining.
  • For the group without TZIELD: have not been treated with TZIELD.
  • Provide written consent or agreement to join, as needed for the patient's age.

Who can't join

  • Started TZIELD more than 6 months before joining.
  • Took part in an earlier clinical trial of TZIELD.
  • Are in a trial of an experimental product, or ended participation in one within 6 months before joining. Other studies that only observe patients are allowed.

Simplified for readability. The official criteria below are what the study team uses.

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

Study sites (37)

CA

CO

CT

FL

GA

IL

IN

KY

MD

MI

MN

MO

NC

NY

OH

PA

TN

TX

UT

WV