A soluble fusion protein, CTLA-4 Ig, is to be used for the prevention of abnormal glucose tolerance and diabetes in relatives at risk of developing the disease. MedDRA version: 20.1 Level: PT Classification code 10066284 Term: Diabetes prophylaxis System Organ Class: 10042613 - Surgical and medical procedures
Conditions
Sponsors
TrialNet Coordinating Center
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Study subjects must be or have: 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 the subject is =65 years) no F.1.3.1 Number of subjects for this age range 0
Exclusion criteria
Exclusion criteria: Potential participants must not meet any of the following exclusion criteria: 1. Abnormal Glucose Tolerance or Diabetes a. Fasting plasma glucose = 110 mg/dL (6.1 mmol/L), or b. 2 hour plasma glucose = 140 mg/dL (7.8 mmol/L), or c. 30, 60, 90 minute plasma glucose during OGTT = 200 mg/dL (11.1 mmol/L) 2. Insulin autoantibodies (mIAA). 3. Immunodeficient or have clinically significant chronic lymphopenia. 4. Have an active infection at time of randomization. 5. Have a positive PPD test result or history of previously treated TB, or positive interferongamma release assay (IGRA) test. 6. Be currently pregnant or lactating, or anticipate getting pregnant within 14 weeks of the last study drug administration. 7. Use of medications known to influence glucose tolerance. 8. Require use of other immunosuppressive agents. 9. Have serologic evidence of current or past HIV, Hepatitis B (positive for Hepatitis B core antibody or surface antigen), or Hepatitis C infection. 10. Have serological evidence of current CMV infection. 11. Have evidence of active EBV infection. 12. Have any complicating medical issues or abnormal clinical laboratory results that interfere with study conduct or cause increased risk. These include pre-existing cardiac disease, COPD, neurological, or blood count abnormalities (such as lymphopenia, leukopenia, or thrombocytopenia). 13. Have a history of malignancies. 14. Have Multiple Sclerosis. 15. Have demonstrated allergies to abatacept or any of its excipients (maltose, sodium dihydrogen phosphate monohydrate and sodium chloride).
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: The primary objective of the study is to determine whether treatment of subjects at risk for diabetes with Abatacept results in delay or prevention of abnormal glucose tolerance.;Secondary Objective: Secondary objectives will determine whether treatment with Abatacept is superior to placebo with respect to the incidence of Type 1 Diabetes Mellitus, determine whether treatment with Abatacept is superior to placebo with respect to C peptide responses to oral glucose, as obtained from timed collections during longitudinal tests, to compare the safety and tolerability of Abatacept to placebo, and to assess the effects of treatment on mechanistic outcomes.;Primary end point(s): The elapsed time from treatment randomisation to the development of abnormal glucose tolerance.;Timepoint(s) of evaluation of this end point: 6 Years | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): The elapsed time from the development of abnormal glucose tolerance to the development of type 1 diabetes.;Timepoint(s) of evaluation of this end point: 6 years | — |
Countries
Australia, Finland, Germany, Italy, New Zealand, Sweden, United Kingdom, United States
Contacts
Public ContactJulie Martin
TrialNet Coordinating Center
Outcome results
None listed