GAD-alum was designed to work like a vaccine, hopefully stopping the autoimmune attack soon after it has begun, to preserve beta cell function.
"GAD-alum takes a vaccine kind of approach, and takes the antigen in the autoimmune disease and tries to give it in a way that will vaccinate people so they don't have the destructive autoimmunity," explained Skyler.
Previous research, done by the same group, showed positive effects from the treatment, especially in those treated less than six months after being diagnosed with type 1 diabetes, according to the study.
The current study included 334 people between the ages of 10 and 20. All had type 1 diabetes for less than three months, and they had GAD autoantibodies.
The patients were randomly assigned to one of three treatment groups: four doses of GAD-alum; two doses of GAD-alum followed by two doses of placebo; or four doses of placebo.
The most important measure the researchers looked for was levels of C-peptide. C-peptide is a byproduct of insulin production, so rising levels of C-peptide indicate increased levels of insulin. The researchers also measured how much insulin people needed, their average blood sugar levels over the study period, and how often they experienced low blood sugar levels.
While GAD-alum appeared safe and was very well tolerated in this study, it didn't significantly reduce levels of C-peptide, improve blood sugar levels or lessen the need for insulin, according to the study.
Ludvigsson said there may be several reasons that the initial research looked promising, yet this study failed to deliver positive results. One is that they allowed flu vaccines to be given at the same time this trial was ongoing, which could have affected the immune system response somehow, he said. Also, the age of the pati
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