All participants have been included in a Phase II clinical study, DIABGAD-1, in which Diamyd Medical’s diabetes vaccine Diamyd, in a unique combination with other drugs, is tested in children and adolescents recently diagnosed with type 1 diabetes.
The first results from the researcher initiated study will thereby be available in the beginning of 2015.
The study, DIABGAD-1, which is the first study of its kind, combines the diabetes vaccine Diamyd with vitamin D and the anti-inflammatory drug ibuprofen. The Phase II study also evaluates the effect of a double dose of Diamyd and the protein GAD, which is the active substance in Diamyd®. The purpose of the treatment is to preserve the body’s own insulin producing capacity and ability to control the blood sugar level in children and adolescents newly diagnosed with type 1 diabetes.
The study will continue for a total of 30 months after all participants have been included, with a first analysis focusing on immunological markers already after 6 months. Since the final participant now has been included, the first analysis will be initiated at the end of 2014 and the results can be presented in the beginning of 2015.
“We strongly believe in attacking the disease process underlying type 1 diabetes simultaneously from several angels through the combination of our diabetes vaccine Diamyd® with other therapeutics, and this is one of the first such studies in the world,” says Peter Zerhouni, President and CEO of Diamyd Medical. “I am very happy and grateful that so many children and adolescents with their families have chosen to participate in the study and also for the strong commitment from the clinical researchers and other staff.”
The study is conducted at nine pediatric diabetes clinics in Sweden. It is researcher initiated and led by Professor Johnny Ludvigsson at Linköping University. The clinics have now included a total of 64 children and adolescents, between 10 and 18 years of age, recently diagnosed with type 1 diabetes.