Abatacept and GAD-alum to slow progression of type 1 diabetes

Abatacept (Orencia), an immune system modulator and GAD-alum, an antigen based therapy found beneficial for patients with type 1 diabetes. TrialNet researchers are conducting a series of studies to test ways to prevent or delay progression of type 1 diabetes. Results of two studies testing drugs to slow or stop the immune system’s attack on insulin-producing cells in people newly diagnosed with type 1 diabetes will be presented at the American Diabetes Association’s (ADA) 71st Scientific Sessions in San Diego and simultaneously published online in the Lancet.

The studies were conducted by the National Institutes of Health’s international network of researchers, Type 1 Diabetes TrialNet Study Group, led by the National Institute of Diabetes and Digestive and Kidney Diseases.

Both TrialNet studies aimed to preserve secretion of insulin, the hormone that controls blood glucose levels; one with the drug abatacept, and the other with a vaccine called glutamic acid decarboxylase (GAD). When type 1 diabetes is diagnosed, most patients retain a limited ability to make insulin, which is generally lost rapidly over the following one to two years. All study participants received intensive management of their diabetes during the trial, with a goal of keeping HbA1c levels within current ADA recommendations.

In the first study, abatacept (Orencia), an immune system modulator currently used to treat several inflammatory diseases, was evaluated in 112 people, ages 6 to 36, with newly diagnosed type 1 diabetes. Participants were randomized to receive injections of either abatacept or placebo over two years. The group treated with abatacept had a 9.6 month delay in the progression of loss of insulin production. After two years, a marker for the production of insulin was 59 percent higher in the participants treated with abatacept compared to the placebo group. Long-term retention of the ability to make even small amounts of insulin is associated with better glucose control and improved outcomes in diabetes.

In the second study, GAD-alum, an antigen based therapy aiming to suppress the immune response, was tested in 145 people, ages 3 to 45, with newly diagnosed type 1 diabetes. Participants were randomized into three groups to receive two or three doses of GAD-alum or alum alone over 4 to 12 weeks. During one year of treatment, the vaccine showed no evidence of preserving insulin secretion.

Adverse effects were minimal for both drugs, especially among children, who account for the majority of people with type 1 diabetes.

Source: TrialNet, USA

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Abatacept and GAD-alum to slow progression of type 1 diabetes
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