Children at high risk of developing type 1 diabetes were given oral insulin every day. The results showed their immune system answered without causing hypoglycemia, according to the results of a small study, published in the Journal of the American Medical Association.
In a double-blind trial called Pre-POINT, 25 children from countries like Austria, Germany, the United Kingdom and the United States were given important doses of insulin or placebo every day for 3 to 18 months. At 2.5 mg of insulin, saliva IgA binding to insulin, IgG binding to insulin, or CD4+ T-cell proliferative responses to insulin were monitored in two of 10 (20%, 95% CI 0.1-45) children who were treated with placebo, but also in one of of six (16.7%, 95% CI, 0.1-46) of the kids treated with insulin, announced Ezio Bonifacio, PhD, at Technische Universität Dresden in Germany, and his colleagues.
“These findings support the need for a phase 3 trial to determine whether oral insulin can prevent islet autoimmunity and diabetes in such children,” Bonifacio’s team said.
“Unique in our study is that we gave the insulin as a prophylactic vaccine to children before they had any signs of the destructive immune response that leads to type 1 diabetes,” mentioned co-author Anette Ziegler, MD, of the Technische Universität Munich, in another press statement.
The subjects of the study were chosen because of their family history of type 1 diabetes, but also because of their genetic profile that exposed them to high risks for development of the dangerous disease. Although scientists did not find hypoglycemia, insulinoma-associated antigen 2, autoantibodies to glutamic acid decarboxylase, IgE responses to insulin, or diabetes among the children on insulin, they did discover that 67 adverse effects happened in the insulin group, and only 35 in the placebo group, none of which were believed to be treatment-related.
Participants were recruited from 2009 to 2013. Eligible kids were aged 2 to 7 years-old and had a high risk of developing type 1 diabetes, a factor which was determined by the child’s family members whom suffer from the disease and the genetic pattern of those members.
Infections were the most spread adverse events reported, with two serious cases, but neither was connected to the insulin capsules, according to the researchers.
The study was a limited one, with a small sample size. “These children represent less than 1% of children who ultimately develop type 1 diabetes, and it is possible that the immune efficacy findings may not be the same in children with lower genetic risk,” the authors said.
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