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 @ 12:15 PM
Ignite Modification Date:
2025-12-24 @ 12:15 PM
NCT ID:
NCT01030861
Eligibility Criteria:
Inclusion Criteria:
* Between ages of 8-45 years
* Have a relative with type 1 diabetes
* If first degree relative must be 8-45 years old (brother, sister, parent, offspring)
* If second degree relative must be between 8-20 years old (niece, nephew, aunt, uncle, grandchild, cousin)
* Abnormal glucose tolerance by OGTT confirmed with 7 weeks of baseline visit \[fasting blood glucose greater than 110mg/dL or and less than 126 mg/dL OR 2 hour glucose greater or equal to 140 mg/dL and less than 200 mg/dL OR 30, 60, or 90 minute value on OGTT greater than or equal to 200 mg/dL\]
* Presence of at least two confirmed diabetes autoantibodies
Exclusion Criteria:
* type 1 diabetes previously diagnosed or detected at screening \[fasting glucose greater or equal to 126 mg/dL or 2 hour glucose greater or equal to 200 mg/dL\]
* abnormalities in blood counts, liver enzymes, international normalised ratio (INR),
* positive purified protein derivative (PPD) test
* vaccination with live virus within 6 weeks of randomization
* evidence of acute infection based on laboratory testing or clinical evidence
* serological evidence of past current or past HIV , hepatitis B, or hepatitis C infection
* Be currently pregnant or lactating
* Prior treatment with study drug
* Prior treatment with other monoclonal antibody in past one year
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
8 Years
Maximum Age:
45 Years
Study:
NCT01030861
Study Brief:
Protocol Section:
NCT01030861