EUCTR2013-002249-13-FI
Active, not recruiting
Phase 1
CTLA-4Ig (Abatacept) for Prevention of Abnormal Glucose Tolerance and Diabetes in Relatives at Risk for Type 1 Diabetes Mellitus
TrialNet Coordinating Center0 sites206 target enrollmentJuly 15, 2014
ConditionsA soluble fusion protein, CTLA-4 Ig, is to be used for the prevention ofabnormal glucose tolerance and diabetes in relatives at risk ofdeveloping the disease.MedDRA version: 20.1Level: PTClassification code 10066284Term: Diabetes prophylaxisSystem Organ Class: 10042613 - Surgical and medical proceduresTherapeutic area: Diseases [C] - Nutritional and Metabolic Diseases [C18]
DrugsAbatacept (Orencia)
Overview
- Phase
- Phase 1
- Intervention
- Not specified
- Conditions
- A soluble fusion protein, CTLA-4 Ig, is to be used for the prevention ofabnormal glucose tolerance and diabetes in relatives at risk ofdeveloping the disease.
- Sponsor
- TrialNet Coordinating Center
- Enrollment
- 206
- Status
- Active, not recruiting
- Last Updated
- last year
Overview
Brief Summary
No summary available.
Investigators
Eligibility 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 \<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
Exclusion Criteria
- •Potential participants must not meet any of the following exclusion
- •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
- •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 interferon\-gamma release assay (IGRA) test.
- •6\. Be currently pregnant or lactating, or anticipate getting pregnant within 14 weeks of the last study drug administration.
Outcomes
Primary Outcomes
Not specified
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Phase 2
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