Phase II study of Diamyd begins
The subjects of the placebo-controlled study are children who are at a high risk of having type 1 diabetes in the future based on a blood test.
Researchers have determined that a child’s autoimmune process changes before the symptoms of type 1 diabetes appear. Months or years before the symptoms surface, the immune system starts to attack the body’s production of insulin cells. The only way to detect this process is through blood screenings.
Children with blood screenings that show this autoimmune system process are considered to be most likely to have type 1 diabetes in the future.
“We have noted a great interest to participate in the study, and there are many candidates in line,” Helena Elding Larsson, a researcher at Lund University and the lead investigator of the study, said. “It is very satisfying to be able to offer these children a study with the aim of preventing or delaying the disease process.”
Half of the study participants will receive two injections of Diamyd, with the other half receiving the placebo. All study participants also will receive Vitamin D to encourage the efficiency of the diabetes vaccine. The study will last five years and participants who develop type 1 diabetes during the study will receive injections of active Diamyd after diagnosis to see the effect.
“Through a blood sample, it is today possible to identify individuals in which the autoimmune process leading to type 1 diabetes has started,” Åke Lernmark, professor of Experimental Diabetes Research at Lund University, said. “It is important to intervene before it is too late and two injections with the diabetes vaccine Diamyd, which has been shown to be safe in studies with more than 1,000 diabetes patients, seem to be the most promising treatment today.”