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

Diseases and Conditions Researched

Abnormal Glucose Tolerance; Type 1 Diabetes

What is the purpose of this trial?

The study is a 2-arm, multicenter, 1:1 randomized, placebo controlled clinical trial.

All subjects will receive close monitoring for development of AGT or T1DM. Subjects will receive Abatacept or placebo and close monitoring for development of AGT or T1DM. To assess the safety, efficacy, and mode of action of Abatacept to prevent AGT and T1DM.

The primary objective is to determine whether intervention with Abatacept will prevent or delay the development of AGT in at-risk autoantibody positive non-diabetic relatives of patients with T1DM.

Secondary outcomes include: the effect of Abatacept on the incidence of T1DM analyses of C-peptide and other measures from the OGTT safety and tolerability and mechanistic outcomes.


Participation Guidelines

Age: 6 Years - 45 Years
Gender: Both

Click here for detailed participation information for this trial.

Sponsor: National Institute of Diabetes and Digestive & Kidney Diseases
Dates:
Last Updated:
Study HIC#: 1211011152