You are receiving this message since your browser does not support Java Script or you have Java Scripts disabled. The following disclaimer is provided as an alternative to the information that would normally be seen on your monitor when you click on a link to a non-federal site.

"You are now leaving the NIDDK website. The NIDDK is not responsible for the content of web pages found on this linked website. Links to nonfederal organizations are provided solely as a service to our users. These links do not indicate an endorsement of these organizations by NIDDK or the federal government."


"*Nationwide studies refer to those offered in every US State."

The Rituximab Study (TrialNet)

Who can participate?
This study is no longer recruiting patients. People were eligible for this study if they:
  • were diagnosed with type 1 diabetes within the past 3 months.
  • were 12 to 45 years of age.
  • had blood tests that showed that their body was still making insulin.
  • had antibodies in their blood that are present in people with type 1 diabetes.
  • were willing to use birth control and take urine pregnancy tests at every visit (if female and sexually active).
  • agreed to manage their diabetes daily. This means checking blood sugar 3 to 4 times each day and taking multiple insulin injections or using an insulin pump.
What is this study?
The goal of the study is to find out if the medicine rituximab can prevent further insulin-producing beta cell destruction. Rituximab has been successfully used in other illnesses to slow down the immune response.
Why is it being done?
TrialNet researchers hope that rituximab will help to scale down the attack on beta cells and allow them to keep making insulin. Even if rituximab works, patients will still need to take insulin but your blood sugar (glucose) should be easier to control. With your blood sugar controlled better, you'll have less chance of developing: (a) severe hypoglycemia (low blood sugar), and (b) possible long-term problems of diabetes such as blindness, kidney failure, nerve damage, heart attack, and stroke.
If I enroll in this study, what do I have to do?
If you decide to be in the study, you will be randomly (by chance) assigned to receive rituximab or receive a placebo (a pretend medicine that does nothing). The group you are assigned to is decided by chance (as by the toss of a coin or drawing straws). Neither you nor your doctor will be able to choose which group you are in. Also, neither you nor the researchers will know which group you are in.

Two out of three people will be assigned to the group taking rituximab. One out of three people will be assigned to the group taking the placebo. Working with two separate groups in this way allows researchers to compare and measure the benefits of taking rituximab to not taking rituximab.

You will take rituximab or the placebo once a week during the first 4 weeks in the study. It will be given in your vein using an intravenous catheter (an IV) at a clinical center.

Afterwards, you will return to the clinical center for a visit about every 3 months for two years. At those visits, you'll have blood drawn for testing and you'll meet with a doctor. At 5 of the visits, you will take a longer test, called a Mixed Meal Tolerance Test. It requires an IV be put in your arm and you to drink a special protein drink. Then, blood samples will be taken from the IV over the next 2 to 4 hours.
Can I participate in other studies if I participate in this one?
You can’t participate in any other research studies in which treatments are given. However, it might be possible for you to participate in other kinds of studies.
How can I learn more?
Please call the toll free number below or visit the TrialNet website for more information.


Nationwide*


TrialNet Recruitment
Phone: 1-800-HALT-DM1
www.diabetestrialnet.org


*Nationwide studies refer to those offered in every US State.
Last Updated: June 30, 2008

General Inquiries may be addressed to:
Office of Communications and Public Liaison
NIDDK, NIH
Building 31, Rm 9A06
31 Center Drive, MSC 2560
Bethesda, MD 20892-2560 USA
For information about NIDDK programs: 301.496.3583