Registry for Stage 2 Type 1 Diabetes

Launched by SANOFI · Jun 26, 2024

Keywords

ClinConnect Summary

This clinical trial, called the Registry for Stage 2 Type 1 Diabetes, is looking to gather information about patients who have been diagnosed with Stage 2 Type 1 Diabetes (T1D). At this stage, patients have changes in their blood sugar levels but do not yet show obvious symptoms. The study aims to learn more about how the medication TZIELD® (teplizumab) affects these patients, especially those who have started treatment recently or plan to start it. This medication has been approved by the FDA to help delay the progression to Stage 3 T1D, where more serious symptoms and the need for insulin treatment can occur.

To be eligible for this trial, participants must be diagnosed with Stage 2 T1D and either be starting TZIELD treatment or have begun it within the last six months. Both children (aged 8 years and older) and adults can participate, and there are no gender restrictions. Participants will receive standard care and contribute to understanding the long-term effects of the treatment. If you're considering joining, you will be asked to provide consent, and you can expect to be part of a study that aims to improve knowledge about managing Type 1 Diabetes.

Gender

ALL

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