Diabetes Dateline
Summer 2006

Type 1 Diabetes Studies Begin at 18 Sites

Studies Aim to Preserve Insulin Production in Type 1 Diabetes

Eighteen medical centers spread across three continents have launched a series of new clinical studies funded by the National Institutes of Health (NIH) to determine how to slow or stop the onset or progression of type 1 diabetes in newly diagnosed patients and those at risk of developing the disease.

Two of the studies that are part of the clinical trial series called Type 1 Diabetes TrialNet examine how to safely preserve insulin production in people who were diagnosed with type 1 diabetes in the previous 3 months.

In the first study, participants are randomly assigned to receive either the experimental drug mycophenolate mofetil (MMF), MMF plus daclizumab, or a placebo. In the second study, participants are randomized to receive either Rituximab or a placebo.

TrialNet researchers are also conducting a pilot study to see if nutritional intervention can prevent type 1 diabetes in infants less than 5 months old who have close family members with the disease.

Another study in the series is probing the causes of type 1 diabetes by examining immune and metabolic activity that occurs before diabetes symptoms develop. The study will screen first-degree relatives ages 1 to 45 of those with type 1 diabetes and second-degree relatives ages 1 to 20.

Cutting-Edge Strategies

Type 1 diabetes, previously called juvenile onset diabetes, accounts for 5 to 10 percent of all diagnosed diabetes cases in the United States, affecting about 1 million people. The disease is caused by a combination of genetic and environmental factors and usually begins during childhood or young adulthood.

“Even though improved treatment for type 1 diabetes has led to longer and healthier lives for those affected, the disease still exacts a terrible toll, both in the burden of care required, and in the complications that can develop after decades of having the disease,” said Ellen Leschek, M.D., TrialNet’s program director at the National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK).

“We know that residual beta cell function makes diabetes easier to control and reduces the risk of complications,” Leschek said. “TrialNet researchers are looking at cutting-edge strategies to preserve the insulin-producing beta cells in trials that are currently underway and are planning trials to look at the possibility of preventing the onset of type 1 diabetes in high-risk people.”

TrialNet is funded by the NIDDK, the National Institute of Child Health and Human Development, and the National Institute of Allergy and Infectious Diseases within the NIH. The Juvenile Diabetes Research Foundation and the American Diabetes Association also support the research.

Visit www.diabetestrialnet.org for more information about the TrialNet studies and how to join them.

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NIH Publication No. 06–4562
September 2006