Clinical Trials Will Focus on Studying and Preventing Type 1 Diabetes

People at risk for developing type 1 diabetes, as well as those who have been newly diagnosed, will now be able to join clinical trials testing promising new approaches to studying, treating and hopefully preventing type 1 diabetes. Type 1 Diabetes TrialNet, also known simply as TrialNet, is a collaborative network of 18 clinical centers in the U.S., Canada, Europe, and Australia . These clinical centers are made up of diabetes researchers, immunology experts, and specialized laboratories and facilities - all dedicated to testing new approaches to understanding, treating and preventing type 1 diabetes.
TrialNet provides an efficient network to:

• identify people at risk for type 1 diabetes
• investigate possible treatment to prolong the “honeymoon” period in people newly diagnosed with type 1 diabetes
• test the ability of promising new agents to delay or prevent the disease.

A previous study, Diabetes Prevention Trial – Type 1, provided researchers a better understanding of the autoimmune process that leads to type 1 diabetes. University of Florida pediatric endocrinologist, Dr. Desmond Schatz, has provided leadership for both DPT-1 and Trial Net, its follow-up study. The University of Florida is responsible for supervising clinical affiliate sites in northern Florida, Georgia, North Carolina, South Carolina, and Tennessee.

Natural History Studies: Recruitment for TrialNet’s Natural History Study began in mid March 2004. The Natural History Study seeks to learn more about what causes type 1 diabetes and to better define predictors (markers) of the disease process. The study will closely monitor individuals who are at risk of developing type 1 diabetes.
To be screened in the Natural History study, you must be:

• 1 to 45 years of age with a first-degree relative - a mother, father, brother, sister, or child - with type 1 diabetes, or
• 1 to 20 years of age with a second-degree relative – an aunt or uncle, cousin, niece or nephew, or grandparent – with type 1 diabetes

Prevention Studies: Prevention studies are currently being developed to determine whether new therapies (medications) can delay, or prevent, the onset of type 1 diabetes.

Intervention Studies: Intervention studies will attempt to preserve the remaining insulin secretion in people newly diagnosed with type 1 diabetes. Research has already shown that, even after a diagnosis of type 1 diabetes, the immune system continues to destroy beta cells, making blood glucose (sugar) harder and harder to control for many people.

One intervention study under way is called the MMF/DZB Study after the medications Mycophenolate mofetil (MMF or CellCept®) and Daclizumab (DZB or Zenapax®). This study has recruited the needed number of patients.

TrialNet researchers are currently developing other protocols for several medications that have shown promise in earlier studies related to early intervention.

TrialNet is funded by the NIDDK, the National Institute of Child Health and Human Development, and the National Institute of Allergy and Infectious Diseases, all parts of the National Institutes of Health under the Department of Health and Human Services. The Juvenile Diabetes Research Foundation and the American Diabetes Association also support the initiative.

For information about clinical affiliate sites within northern Florida, Georgia, North Carolina, South Carolina, and Tennessee, call (352) 334-0857 or toll free, (800) 749-7424, dial 1, extension 334-0857. Roberta Cook, RN, BSN, CDE, is the Clinical Trial Coordinator; Annie Abraham is the Recruitment Coordinator at (352) 334-1358.

To locate TrialNet clinical centers and/or affiliate sites in other states, call 1-800-HALT-DM1 (1-800-425-8361).

TrialNet is sponsored by the National Institute of Diabetes and Digestive and Kidney Diseases; National Institute of Child Health and Human Development; National Institute of Allergy and Infectious Diseases; Juvenile Diabetes Research Foundation, and American Diabetes Association.