Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 9:55 PM
Ignite Modification Date:
2025-12-24 @ 9:55 PM
NCT ID:
NCT02620332
Eligibility Criteria:
Inclusion Criteria:
* Clinical diagnosis of Type 1 diabetes
* Age 18-45 years
* Maximum of 4 years from diagnosis
* Evidence of ≥1 autoantibody against β-cell autoantigens
* Possession of the HLA-DR4 (DRB1\*0401) genotype
* Residual β-cell function (peak C-peptide \>200)
Exclusion Criteria:
* Females who are pregnant, breast-feeding or not using adequate forms of contraception.
* Use of β-cell stimulants, immunosuppressive or immunomodulatory therapies, including systemic steroids within 1 month prior to randomization, any monoclonal antibody therapy given for any indication and any antigen-specific
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
45 Years
Study:
NCT02620332
Study Brief:
Protocol Section:
NCT02620332