CTLA-4 Ig (Abatacept) in Recent Onset Diabetes

• Brief summary of study
• Who can be in the study?
• Where can I find clinical centers who are recruiting?

Brief summary of study

Type 1 diabetes is an autoimmune disease. This means that your immune system, the part of the body that helps fight infections, mistakenly attacked the cells in your body that produced insulin. These cells, called beta cells, are found in your pancreas.

This attack probably started years ago. Once many of your beta cells were damaged, your blood glucose levels went too high, and you had to start taking insulin by injection.

At this point, when you have had diabetes for less than three months, you may have beta cells left that produce some insulin. People who continue to make a little insulin may have fewer problems with low blood glucose (hypoglycemia). They may also have an easier time keeping their blood glucose levels in the normal range. This lowers the risk of the long-term complications of diabetes.

Right now, there is no proven treatment that will protect the remaining beta cells. In type 1 diabetes, the body's immune system keeps destroying them. By a few years after diagnosis, most people with type 1 diabetes are making no insulin of their own.

In this study, we are testing a drug called abatacept that might protect the remaining beta cells from further destruction. We want to see if abatacept might help people continue to make a little of their own insulin. This research study will compare people who get abatacept with those who do not get abatacept.

The Study Drug

Abatacept was approved by the U.S. Food and Drug Administration (FDA) in December 2005 for the treatment of rheumatoid arthritis, another autoimmune disease. Abatacept works by interrupting one of the steps in the autoimmune attack.

In this study, we will see if abatacept will interrupt the autoimmune attack that is going on in people recently diagnosed with type 1 diabetes.

Abatacept is given through an intravenous (IV) infusion, with a needle placed in a vein in the arm. The infusion lasts for 30 minutes.

Study Design

Two-thirds of the people in this study will get infusions of abatacept. They are in the treatment group.

One third of the people in this study will get infusions that look like abatacept but have no active drug. This is called a placebo infusion. The people getting the placebo infusions are in the control group.

Both groups will get 27 infusions over two years with an infusion occurring every 28 days. You will be asked to return for additional visits for up to two years after completing the infusions.

You can't choose your group. A computer will choose your group for you. It's by chance, like drawing straws. This is called random assignment, or randomization.

This study is double-masked. While the study is going on, neither you nor your study team will know if you're in the treatment group or the control group. At the end of the study, we will tell you whether you were in the treatment group or the control group.

As a research volunteer, you can decide to stop being in this study at any time. We hope that you will stay in the study. You will be helping us learn more about how to help people with diabetes.

Who can be in the study?

To be screened for the abatacept Study, research volunteers need to be:

[ ] 6 to 45 years old
[ ] diagnosed with type 1 diabetes less than 3 months ago

Screening tests, including blood tests, will help decide who can participate in this study.

Where can I find clinical centers that will be participating in the study?

If you wish to see if you might be eligible for this study, complete the online screening or call toll free anytime:

1- 800- HALT- DM1 (1-800-425-8361)

Or contact one of the participating clinical centers directly.

Information will be maintained in a confidential manner.

Regional Area

Participating Clinical Center

Alaska, Idaho, Montana, Oregon, and Washington

Benaroya Research Institute at Virginia Mason
Seattle, WA
800-888-4187

Colorado, Kansas, Missouri, Utah, and Wyoming

Barbara Davis Center for Childhood Diabetes
University of Colorado
Aurora, CO
800-572-3992

Delaware, District of Columbia, Maryland, Ohio, Pennsylvania, Virginia, West Virginia and Southern New Jersey

Children's Hospital of Pittsburgh of UPMC
Pittsburgh, PA
412-692-5210
Karen.Riley@chp.edu

Canada

The Hospital for Sick Children
Toronto, Ontario
866-699-1899

New York and Northern New Jersey

Naomi Berrie Diabetes Center
Columbia University
New York, NY
212-851-5425
emg25@columbia.edu

Indiana, Illinois, Kentucky and
Lower Peninsula Michigan

Riley Hospital for Children
Indiana University
Indianapolis, IN
866-230-8486
pedsdiab@iupui.edu

Maine, Massachusetts, New Hampshire, Rhode Island, and Vermont

Joslin Diabetes Center
Children's Hospital Boston
Boston, MA
800-242-5836

Northern California and Hawaii

University of California, San Francisco
San Francisco, CA
415-514-3730
kfraser@diabetes.ucsf.edu

Central California and Nevada

Stanford University Medical Center
Stanford, CA
877-232-5182
dwilson@stanford.edu

Northern California and Hawaii

University of California, San Francisco
San Francisco, CA
415-353-9084
kfraserh@ucsf.edu

Georgia, North Carolina, South Carolina, Tennessee, and Northern Florida

Vanderbilt

Alabama, Arkansas, Louisiana, Mississippi, Southern Florida, and Puerto Rico

University of Miami
School of Medicine
Miami, FL
305-243-3781
dmatheso@med.miami.edu
cblaschke@med.miami.edu

Iowa, Minnesota, Nebraska, North Dakota, South Dakota, Wisconsin, and Upper Peninsula Michigan

University of Minnesota
Minneapolis, MN
800-688-5252, Ext. 58944
schmi094@umn.edu
pete5601@umn.edu

New Mexico, Oklahoma, and Texas

University of Texas
Southwestern Medical Center at Dallas
Dallas, TX
214-648-4844
marilyn.alford@utsouthwestern.edu
maria.pruneda@utsouthwestern.edu

Australia and New Zealand

Walter and Eliza Hall Institute of Medical Research
Parkville, Victoria
+61-3-93452555
fwilliams@wehi.edu.au