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.

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.

Patients in the US diagnosed with Stage 2 Type 1 Diabetes

Qualified researchers may request access to patient level data and related study documents including the clinical study report, study protocol with any amendments, blank case report form, statistical analysis plan, and dataset specifications. Patient level data will be anonymized and study documents will be redacted to protect the privacy of trial participants. Further details on Sanofi's data sharing criteria, eligible studies, and process for requesting access can be found at: https://vivli.org