The MMF/DZB Study

Status: No Longer Recruiting

Eligibility Criteria

To join this study, you must fulfill the conditions below:

• Have been diagnosed with type 1 diabetes within the past 3 months.
• Be 12 to 35 years of age.
• Have blood tests that show you are still making insulin. Have antibodies in your blood that are present in people with type 1 diabetes. (An antibody is a protein made by the immune system that fights infection. People with type 1 diabetes have antibodies against insulin and parts of the insulin producing cells.)
• If female and sexually active, be willing to use birth control and undergo urine pregnancy tests at every visit.
• Be willing, to the best of your ability, to make all scheduled visits to the clinic and follow your study instructions.
• Be willing to accept assignment to any of the three treatment groups and be willing to stay in that group for the length of the study.
• Be willing to comply with "intensive management" of your diabetes. The goal of this type of diabetes management is to keep your blood sugar as close to normal as possible. This involves checking your blood sugar 3 to 4 times each day and taking insulin by injections or an insulin pump to keep your blood sugar as close to normal as possible

You cannot be in the rituximab study, if you:

• Have any medical conditions that would make it difficult and unsafe for you to be in this study.
• Have a Body Mass Index (BMI) greater than the 95th percentile for your age and gender. Your Body Mass Index (BMI) is a measure of your weight for your height.
• Have certain infections like HIV, hepatitis, and tuberculosis.
• Have had vaccinations within 6 weeks of starting the study.
• Require medicines (like steroids) for other conditions that make your immune system less active.
• Currently be pregnant or within 3 months of having been pregnant.
• Currently be nursing or within 6 weeks of having stopped nursing.
• Anticipate getting pregnant at any time during the study.

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:

• Active MMF with DZB placebo
• Active MMF with Active DZB
• MMF placebo with DZB placebo

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.

Benefits

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.

Participation

To see if you might be eligible for this study and for a referral to a TrialNet site:

• Complete the online screening,
• Call toll free anytime 1 - 800 - HALT - DM1 (1-800-425-8361)
• Contact a participating center.

The blood test to determine whether or not you are at risk for Type 1 Diabetes is part of the Natural History study. Please see the list of Clinical Centers for more information.

Information will be kept confidential.