In order to increase the scientific value of the research on preventative treatment with the Diamyd® diabetes vaccine, the research team at Lund University, who have been driving the DiAPREV-IT study since 2009, decided to expand the dataset with additional children at high risk of presenting with type 1 diabetes. Therefore, after discussions with the Swedish Medical Products Agency and Diamyd Medical, a new, larger study of a similar design to DiAPREV-IT is being planned, in which new research findings are taken into consideration.
The new study, named DiAPREV-IT 2, is a researcher-initiated study comprising 80 children aged four and above with a 50-percent risk of developing clinical symptoms of type 1 diabetes within five years. The study is double-blind and placebo-controlled, which means that half of the children will receive two doses of Diamyd® and half will receive placebo (non-active substance). No-one will know who has received what until the end of the five year study. The intent is to see if the diabetes vaccine can prevent or delay the onset of clinical symptoms of type 1 diabetes in the children. Simply delaying the onset of the disease with the help of Diamyd® would be a major medical success. Those children that develop clinical symptoms of type 1 diabetes during the study will receive injections of active Diamyd® after diagnosis, irrespective of whether they have received active or placebo as preventative treatment. In this manner, it will also be possible to follow the efficacy of the diabetes vaccine in new-onset patients.
The study will be much like the ongoing DiAPREV-IT study, except that supplementation of vitamin D is included for all participants and that the latest findings, namely that two early stages of type 1 diabetes exist prior to clinical onset, have been taken into account. The study will stratify the participants according to the stage they belong to at the start of the study. The first stage comprises children with two or more auto-antibodies directed at their own insulin-producing cells, but with normal glucose metabolism. The other stage is children with both auto-antibodies and an impaired glucose metabolism. Vitamin D supplement is given to lower the immune system’s inflammatory components to, thereby, increase the diabetes vaccine’s tolerance-inducing effect with the aim of maintaining the ability to produce insulin.
“The planned strategy means that more children who have entered the autoimmune process, but who have not yet been diagnosed with type 1 diabetes, can obtain access to the diabetes vaccine both prior to and following any diagnosis,” says Anders Essen-Möller, Chairman of Diamyd Medical. “This could shorten the path to market acceptance.”
Source: Diamyd pressrelease