RECENT ONSET OF TYPE 1 DIABETES: AGE 8 TO 30 YEARS WITHIN 12 MONTHS OF DIAGNOSIS - TREATMENT OF TYPE 1 DIABETES MELLITUS WITH HOKT3Y1 (ALA-ALA/ANTI-CD3)

Diabetes Endocrinology Research Center (DERC)

DERC was established to support and enhance interactions among an outstanding team of investigators involved in Type 1 or 2 diabetes research.

UCSF JDRF CENTER (CCCT)

The mission of the center is to develop and test a new approach to the treatment of Type 1 diabetes by bringing together researchers from 5 academic institutions and 1 commercial partner.

RECENT ONSET OF TYPE 1 DIABETES: AGE 8 TO 30 YEARS WITHIN 12 MONTHS OF DIAGNOSIS - TREATMENT OF TYPE 1 DIABETES MELLITUS WITH HOKT3Y1 (ALA-ALA - ANTI-CD3)

Study Name: Treatment of Type 1 Diabetes Mellitus with hOKT3γ1 (Ala-Ala/anti-cd3)

Study Sponsors: National Institute of Health

Principal Investigator: Stephen E. Gitelman, M.D., Director of the Pediatric Diabetes Program at U.C.S.F.

Who can sign up for this study? Volunteers must be between 8 to 30 years old and have been diagnosed with type 1 diabetes within the past 12 months. Volunteers must also weigh at least 60.5 pounds.

In addition, volunteers cannot have any of the following conditions:

No infectious mononucleosis-like illness within the last 3 months prior to enrollment
No concurrent autoimmune disease
No concurrent asthma
No active infection
No vaccination with a live virus within the past six weeks

What is this study about? The UCSF Pediatric Clinical Research Program is conducting a study on an investigational (not approved by the FDA) medication to see if it will stop the destruction of the insulin making cells in people diagnosed with type 1 diabetes within the last 12 months.

What will happen in this study? Volunteers who qualify and are enrolled will receive one 14-day treatment of either the study drug or a placebo. All volunteers will be monitored for 1 year to asses their overall diabetes health and to perform laboratory testing to determine the effects of the treatment to their immune system and beta cells. This will require several visits to UCSF for laboratory testing during this period.

How long will this study last? Each volunteer will be followed for 1 year.

Reimbursement: You will not be charged for any of the study treatments and may be eligible for reimbursement for your time, effort and travel expenses.

For more information: Please contact Study Coordinator Christine Torok, R.N. at 415-353-9089 or email at Christine.Torok@ucsf.edu.

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