New Diabetes Clinical Research Trials

Program:

Diabetes Clinical Research Program

Update on Current and Planned Studies

The Diabetes Clinical Research Unit (DCRU) is conducting a wide range of studies to find new ways to prevent, treat and cure diabetes. A current emphasis of the DCRU is intervention studies for preservation of insulin secretion. Following is an update on intervention studies and other diabetes research studies.

Intervention Studies

Intervention studies for individuals with Type 1 diabetes: The goal of these studies is to preserve insulin secretion in individuals newly diagnosed with type 1 (autoimmune) diabetes. The persistence of endogenous insulin production has been associated with important clinical outcomes, specifically reduction in severe hypoglycemia and complications, so intervention even after diagnosis is likely to have significant benefit for people with diabetes. Each of the following studies is looking at unique ways to disrupt the autoimmune attack. Notably, many of the drugs being tested in autoimmune diabetes have been used successfully to treat other autoimmune disease or cancers.

MMF/DZB (Type 1 diabetes TrialNet): this fully-enrolled trial is looking to see if two medications currently approved for use in transplant patients will halt the destruction of insulin producing cells in persons newly diagnosed with Type 1 diabetes.

Rituximab (TrialNet): the goal of the Rituximab study is to determine if Rituximab (anti-CD20) can preserve beta cell function in persons newly diagnosed with Type 1 diabetes by turning off the immune attack on beta cells. This study is fully enrolled.

Abate(Immune Tolerance Network): The AbATE Trial is testing a new experimental antibody therapy known as hOKT3γ1(Ala-Ala) to determine whether it can halt any further loss of beta cells by establishing a state of immune "tolerance" towards the beta cells.Currently enrolling.

Il-2 and Rapa (Immune Tolerance Network): Studies in animals have suggested that combining the medicines IL-2 or interleukin-2 (Proleukin) and Sirolimus (Rapamune) may augment immune regulatory T cells while decreasing inhibiting autoaggressive lymphocytes. While both of these medicines are already in use for patients with other conditions, they have not been used together, and have not yet been used to treat Type 1 diabetes. The goal of this first study is to evaluate this combination for safety, and BRI is currently the only site testing IL-2 and Rapa. If the combination of medication is shown to be safe the study may then move into a phase 2 trial and will be conducted by other sites in the Immune Tolerance Network. Currently enrolling.

CTLA-4 Ig (Abatacept) (TrialNet): We are very close to enrolling participants into this new study. Abatacept is currently FDA-approved for use in rheumatoid arthritis, and has been shown to be well-tolerated by children in a study testing the drug as a treatment for juvenile idiopathic arthritis. CTLA-4 Ig inhibits/regulates T cell function, but does not deplete T cells in humans. The safety profile reported in human clinical trial appears to be better than any other immunosuppressive medication used to preserve beta cell function. We will soon be testing this in children as young as six years of age.

Bayhill BHT-3021 (Bayhill Therapeutics, Inc.) The purpose of this study is to evaluate the safety of an experimental agent BHT-3021 in participants with Type 1 diabetes. This is the first clinical research study of BHT-3021 in humans, and is not yet approved by the FDA. BHT-3021 is designed to decrease abnormal immunity to insulin, and it is also thought that BHT-3021 may decrease damage to the insulin-producing cells in the pancreas. Recruitment will begin in the near future.

GAD65 (Diamyd) Vaccine (TrialNet): Glutamic acid decarboxylase (GAD) is one of the major autoantigens involved in the autoimmune process underlying T1DM. GAD-Alum is Recombinant human (rhGAD65) and is used as a potential antigen-specific immune modulator. Previous studies have shown that it may slow or prevent autoimmune destruction of pancreatic islet cells for as long as 15 months by redirecting the immune response through vaccination. Enrollment into this trial will likely begin later this year.

Other Studies

Oral Insulin Prevention Trial (TrialNet) This study is testing oral insulin for relatives of people with Type 1 diabetes to see if oral insulin helps to delay or prevent Type 1 diabetes. Results from a recently completed study, DPT-1, suggest that oral insulin might delay or prevent Type 1 diabetes in some people found to be at risk. Currently enrolling.

Translational Research: Juvenile Diabetes Research Foundation (JDRF) This JDRF natural history study is looking at the causes of diabetes and other autoimmune diseases. The study will investigate genetic markers associated with autoimmune disease and look at measures of autoimmunity such as antibodies and immune system activity. Currently enrolling.

Type 1 Diabetes Genetics Consortium As the North American Coordinating Center for the Type 1 Diabetes Genetics Consortium, BRI has completed enrollment in the study of families with two siblings with Type 1 diabetes, and is now studying the genetics of populations where diabetes is not as prevalent (African-American and Mexican-American populations). Currently enrolling for these populations

The Natural History Study of the Development of Type 1 Diabetes (TrialNet) This study will look at people at increased risk for Type1 diabetes to learn more about how Type1 diabetes occurs. This study is screening close blood relatives of people with Type1 diabetes because they have a 10 to 15 times greater risk for developing the disease than people with no family history.