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Information for Study Participants
The MMF/DZB Study
Status: No Longer Recruiting
To join this study, you must fulfill the conditions below:
You cannot be in the rituximab study, if you:
About this Study
The goal of this study is to find out if two medicines are able to stop the ongoing destruction of beta cells in your body. The two medicines are called Mycophenolate mofetil (MMF/CellCept®) and Daclizumab (DZB/Zenapax®). They work by making your immune system less active. TrialNet researchers hope that these medicines will help your beta cells keep the ability to make some insulin and keep your blood sugar (glucose) levels closer to normal. Even if the medicines work, you will still need to take insulin shots but your blood sugar may be easier to control. Better controlled blood sugar may help reduce long-term complications of diabetes such as blindness, kidney failure, nerve damage, heart attack and stroke.
For this study, participants will take MMF alone, MMF and DZB together, or a placebo. A placebo is a "pretend" medicine that looks real but is not active. The reason that some patients will take a placebo is to determine the benefit of the study medicine compared to not giving a medicine.
What will I be asked to do?
In this study, you will be randomly assigned to one of three groups:
Random assignment means that a participant has an equal chance of being assigned to any group. This is done to make sure that the groups are as similar as possible at the beginning of the trial. Group assignment is decided by chance alone (similar to the toss of a coin). Also, this trial will be masked. This means that neither you nor the researchers know to which group you have been assigned.
If you decide to be in this study, you will be taking study medicines for two years. MMF or MMF placebo will be given as pills that you will take 2 or 3 times a day. DZB or DZB placebo will be given into a vein using an intravenous catheter (IV) twice during 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.
Researchers hope that MMF/DZB will help to protect remaining beta cells and their ability to produce insulin after the diagnosis of type 1 diabetes. If the study is successful, this could lead to better blood sugar control and reduced risk for long-term complications. The information gained from these studies may help other people at risk for type 1 diabetes.
To see if you might be eligible for this study and for a referral to a TrialNet site:
Information will be kept confidential.