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NEW ONSET TYPE 1 DIABETES: AGE 6 TO 45 YEARS WITHIN 3 MONTHS OF DIAGNOSIS - ABATACEPT
Drug Name:  Abatacept (CTLA-4 Ig)

Study Name:  Effects of CTLA-4 Ig (Abatacept) on the Progression of Type 1 Diabetes in New Onset Subjects

Study Sponsor:  TrialNet

Principal Investigator:  Stephen E. Gitelman, M.D., Director of the Pediatric Diabetes Program at UCSF

Who can sign up for this study?  Volunteers must be between 6 and 45 years of age and have been diagnosed with type 1 diabetes within the last 3 months.

What is this study about? The U.C.S.F. Pediatric Diabetes Clinical Research Program is conducting this study to see if a medication, Abatacept, can be used as a possible treatment for people with newly diagnosed type 1 diabetes.  Type 1 diabetes is an autoimmune disease.  The immune system attacks and destroys the cells in the body that make insulin.  The goal of this study is to see if Abatacept can interrupt the autoimmune attack and save remaining insulin producing cells.  Abatacept is approved by the U.S. Food and Drug Administration (FDA) for the treatment of rheumatoid arthritis, another autoimmune disease.  The medication is experimental (not approved by the FDA) for use in type 1 diabetes.

What will happen in this study?  Qualified volunteer subjects will be randomly selected to receive either Abatacept or a placebo (inactive substance that looks like Abatacept, but has no medicine in it).  Subjects will have a 2 out of 3 chance to receive Abatacept and a 1 out of 3 chance to receive the placebo.  Neither the subject nor the researchers will know who is getting Abatacept and who is getting the placebo.

Subjects will be scheduled to have study visits at UCSF where Abatacept or the placebo will be given through a vein in the arm (intravenous or IV infusion) over a 30 minute period.  Subjects will get an infusion about once a month for 2 years.  At the study visits, subjects will be observed for any side effects and will have tests and exams done to check on the subjects’ health and to see how much insulin they are making.  At the end of the 2 years of treatment, subjects may be asked to come back every 6 months for up to 2 more years for follow up testing.

How long will this study last?  The study will last up to 4 years:  2years of treatment and up to 2 years of follow-up

Reimbursement:  In return for their time, effort, and travel expenses, subjects will be paid $50.00 for each study visit and will have parking costs covered while they are at study visits.  Subjects will not be charged for any study treatments or procedures.

For more information please contact: Please contact Kathleen Fraser at 415-353-9084 or email kfraser@diabetes.ucsf.edu.