The study, approved by the Swedish Medical Products Agency, combines the diabetes vaccine Diamyd with relatively high doses of vitamin D and the anti-inflammatory drug ibuprofen. The purpose of the treatment is to preserve the body’s own ability to control the blood sugar level in children and adolescents newly diagnosed with type 1 diabetes.
The study is called DIABGAD-1 and will also evaluate the effect of a double dose of Diamyd and the protein GAD, which is the active substance in Diamyd. The study will include 60 children and adolescents in Sweden and it will be conducted at pediatric diabetes clinics in Malmö, Lund, Halmstad, Kalmar, Jönköping, Uddevalla, Örebro, Linköping and Stockholm. The study is funded by research grants, while Diamyd Medical is responsible for providing study drug and certain other costs, and can utilize the study results.
DIABGAD-1 is a double-blind, randomized and placebo-controlled Phase II study including a total of 60 participants between 10 and 18 years old, newly diagnosed with type 1 diabetes. The study will comprise a total of 30 months, with a first analysis focusing on immunological markers already after 6 months. The study has been approved by the Swedish Medical Products Agency and is scheduled to start screening patients in the beginning of February 2013. Four different treatment groups, each including 15 participants, will be evaluated: the first group will receive one prime injection of Diamyd and a booster injection 4 weeks later, combined with ibuprofen for 90 days and vitamin D for 450 days; the second group will receive one prime injection of Diamyd and a booster injection 4 weeks later, and vitamin D for 450 days; the third group will receive two prime injections of Diamyd and two booster injections 4 weeks later, and vitamin D for 450 days; and the fourth group will receive placebo only.
Diamyd Medical’s drug development in diabetes originates from the protein GAD, which is the active substance in the company’s diabetes vaccine Diamyd for the prevention and treatment of autoimmune diabetes. Treatment with Diamyd is intended to prevent, delay, or stop the autoimmune attack on the beta cells. The aim is to prevent the onset of autoimmune diabetes, or to preserve the body’s capacity to regulate blood sugar. Studies have shown that even a very small preservation of endogenous insulin secretion and slight improvement of the blood sugar control can significantly reduce the risk of both acute and long-term diabetes complications.