TrialNet-MMF/DZB (TrialNet)

This study is no longer recruiting patients. Persons who had developed type 1 (insulin dependent) diabetes within the last three months and who are between the ages of 12 and 35 were eligible to participate.

The goal of this study is to find out if two immunosuppressive medicines are able to stop the immune system from destroying beta cells in new onset type 1 diabetes patients (within 3 months of diagnosis). The two medicines are called Mycophenolate mofetil (MMF/CellCept®) and Daclizumab (DZB/Zenapax®). These medicines work by making the body’s immune system less active.

Researchers hope that the immunosuppressive medicines can help treat type 1 diabetes and save the remaining beta cells in a new-onset patient. If this approach works, it is hoped that the disease will be easier to control and will cause fewer problems later in life.

For this study, participants will take MMF alone, MMF and DZB together, or a placebo. Participants will be randomly assigned to one of three groups: (1) Active MMF with DZB placebo; (2) Active MMF with Active DZB; or (3) MMF placebo with DZB placebo. Participants will take MMF by mouth two or three times a day for the entire two-year treatment period. Participants will also receive an IV infusion of DZB twice in the first month of the study at a clinical center. You will need to go to the clinical center for visits and tests. For the first month, you will come in every week, then you will come in at month 2 and month 3. After the month 3 visit, visits will occur about every three months. At most visits, you will have blood drawn and meet with a doctor. Occasionally, you will be asked to do a longer test called a “Mixed Meal Tolerance Test” that involves having an IV inserted into your arm. You will then drink a special protein drink and have blood samples taken from the IV over the next 2 to 4 hours.

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