CTLA-4 Ig (Abatacept) FOR PREVENTION OF ABNORMAL GLUCOSE TOLERANCE AND DIABETES IN RELATIVES AT-RISK FOR TYPE 1 DIABETES MELLITUS: TN18

Study ID
STU 122012-026

Cancer Related
No

Healthy Volunteers
No

Study Sites

Contact
Maria Pruneda
214-648-4717
maria.pruneda@utsouthwestern.edu

Principal Investigator
Philip Raskin

Summary

The study is a 2-arm, multicenter, 1:1 randomized, placebo controlled clinical trial. All subjects will receive close monitoring for development of abnormal glucose tolerance (AGT) or type 1 diabetes (T1DM).

Participant Eligibility

1. Participant in TrialNet Natural History/Pathway to Prevention Study (TN01) and thus, a relative of a proband with T1DM.
2. Between the ages of 1-45 years at the time of enrollment in TN01 and age >= 6 at time of randomization in this trial.
3. Willing to provide Informed Consent or have a parent or legal guardian provide informed consent if the subject is <18 years of age.
4. Normal glucose tolerance by OGTT within 7 weeks (no more than 52 days) of baseline (visit 0). If previous abnormal glucose tolerance, has had two consecutive OGTTs with normal glucose tolerance.
a. Fasting plasma glucose < 110 mg/dL (6.1 mmol/L), and
b. 2 hour plasma glucose <140 mg/dL (7.8 mmol/L), and
c. 30, 60, or 90 minute value on OGTT< 200mg/dL (11.1 mmol/L)
5. At least two diabetes-related autoantibodies confirmed to be present on two occasions, not including mIAA. Confirmation of 2 positive autoantibodies must occur within the six months prior to randomization, but the confirmation does not have to involve the same 2 autoantibodies.
6. Weight >= 20 kg at Baseline Visit.
7. If a female participant with reproductive potential, willing to avoid pregnancy and undergo pregnancy testing prior to each infusion.
8. At least three months from date of last live immunization.
9. Willing to forgo live vaccines while receiving treatment on study and for three months following last study drug administration.