is a GAD-based diabetes therapy for the treatment and prevention of type 1 diabetes and LADA. GAD (glutamic acid decarboxylase) is a protein present in the beta cells of the pancreas and is one of the most important targets when the immune system attacks these cells in autoimmune diabetes. Treatment with Diamyd®
is thought to induce tolerance to GAD, thereby intervening in the autoimmune attack and preserving the capacity to produce insulin in patients with autoimmune diabetes, i.e. type 1 diabetes and LADA.
in type 1 diabetes is intended for the treatment of children and adolescents with recent-onset type 1 diabetes and those at high risk of developing the disease. It has been studied in several clinical trials including more than 800 patients with recent-onset type 1 diabetes and two researcher initiated Phase II clinical studies are currently in progress.
in LADA is intended to prevent LADA patients from becoming insulin dependent. The LADA patients are typically adults and are characterized and discriminated from type 2 diabetes patients by elevated levels of antibodies to GAD. Diamyd®
has been evaluated for the treatment of LADA in Phase II clinical trials.
The Autoimmune Process
In type 1 diabetes, destruction of the insulin producing beta cells begins long before any symptoms appear. For unknown reasons, the body's own immune system begins to destroy the beta cells. The symptoms of diabetes only become apparent when 10 to 20 percent of the ability to produce insulin remains. At this point the body does not have enough beta cells left to be able to produce enough of the vitally needed insulin. Typical symptoms are increased urine volumes and increased thirst, as well as increasing fatigue, weakness, hunger and rapid weight loss. Shortly nausea and stomach pain may occur. The condition can rapidly become worse if the patient does not receive care. Sometimes children are even unconscious when they arrive at the hospital on an emergency basis.
The ones affected by the disease must receive immediate treatment with insulin, and often needs to remain in the hospital for several days after the diagnosis. The symptoms of the disease can develop quite rapidly, from a few days to a few months, even though the destruction of the beta cells has been under way for a much longer period. Antibodies against GAD are one of the biomarkers characteristic of the disease. GAD-antibodies can be detected long before any clinical symptoms of the disease appear. The presence of GAD-antibodies and certain other biomarkers identify persons who are at high risk of developing type 1 diabetes.
Despite modern insulin treatment, the fundamental problem of beta cell destruction continues, and finally all of the beta cells are destroyed and the body can no longer produce any insulin at all.