A clinical research consortium sponsored by NIAID and JDRF
The RETAIN Study is a clinical research study evaluating a protein called alpha-1 antitrypsin (AAT) in recently diagnosed type 1 diabetes patients.
AAT is a naturally occurring anti-inflammatory protein that affects immune cells that are thought to be involved in the development of type 1 diabetes. In mice, an injection of AAT can halt the destruction of beta cells, so doctors want to know if it will do the same in people, in a safe manner.
It is important to know that purified AAT is available as a drug called “Aralast NP.” Aralast NP and other drugs like it have been safely used for over 20 years to treat some types of emphysema. However, because it has not been used before in people with type 1 diabetes, it is considered an experimental treatment.
About Participating in the RETAIN Study
A few things you should know:
- participation will last up to two years (12 infusion visits and about 8 follow-up visits)
- participants will receive intravenous infusions of either the study drug or an inactive placebo a total of 12 times
- all study-related care and study drug are provided at no cost to you
- all participants will take part in an Intensive Diabetes Management program that aims to help patients gain better control of their disease and includes regular appointments with our expert diabetes care team
- participation is voluntary and you may quit the study at any time, for any reason
- like any medication, Aaralast NP may have unwanted side effects and there is also no guarantee that Aralast NP will work or that you will receive the active drug (rather than the placebo)
- you may or may not get better in this study but doctors can use what they learn in this study to help people with diabetes in the future
A clinical trial is a research study that involves people who volunteer to take part in a study. It provides a way to learn about the effects of new medicines and/or about new uses for medicines. If you are interested in participating in a clinical trial, it is important that you take the time to learn as much as you can about the study so that you may judge for yourself whether the trial is right for your individual situation.
People choose to participate in clinical trials for many reasons. For some it is a chance to gain access to experimental therapies. For others it is an opportunity to advance medical research. But it is important to remember that participation in a clinical trial is completely voluntary.