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Clinical trials

Diamyd Medical is dedicated to finding a cure for autoimmune diabetes. The Company’s major projects include development of combination regimens with the GAD-based diabetes vaccine Diamyd®, for arresting the destruction of insulin-producing beta cells, as well as GABA for the treatment of diabetes. Six clinical trials are ongoing combining the Antigen Based Therapy Diamyd® with other compounds, including GABA, both within prevention and intervention of type 1 diabetes.

The diabetes vaccine Diamyd® has gone through several levels of clinical trials showing a good safety profile in studies encompassing more than 1000 patients. Overall efficacy in rescuing insulin production has been limited to 16% at p=0.10 in a European Phase III study, whereas good clinical effect has been found in certain predefined subgroups. Currently six clinical trials are ongoing, pursuing combination regimens with the diabetes vaccine Diamyd® and other compounds in order to maximize efficacy while maintaining safety.

The goal of the Antigen Based Therapy Diamyd® is to prevent, stop, delay or slow the destruction of insulin-producing beta cells in the pancreas.

Six clinical trials exploring the safety and efficacy of Diamyd® are currently ongoing; four combination studies aiming to intervene in the autoimmune type 1 diabetes process and two interception studies aiming to prevent type 1 diabetes diagnosis in children at very high risk of developing the disease.

  • DIABGAD-1 – COMBINING DIAMYD® WITH IBUPROFEN AND VITAMIN D
  • Intervention study
    A placebo-controlled study, where Diamyd® is being tested in combination with ibuprofen and vitamin D. The study comprises a total of 64 patients between the ages of 10 and 18, recently diagnosed with type 1 diabetes, and will continue for a total of 30 months. The aim of the combination treatment is to preserve the body’s own capacity to produce insulin. The study runs at nine clinics in Sweden and is led by Professor Johnny Ludvigsson at Linköping University, Sweden. 15 months results from the study are due in the fourth quarter of 2015.

  • DIAGNODE-1 – GIVING DIAMYD® IN LYMPH GLANDS IN COMBINATION WITH VITAMIN D
  • Intervention study
    An open label study, where Diamyd® is administered directly into lymph nodes in combination with treatment with vitamin D. The study comprises five patients between the ages of 18 and 30 newly diagnosed with type 1 diabetes and will continue for a total of 30 months. The aim of the study is to evaluate the safety of the combination treatment and the effect on the immune system and the patients’ insulin producing capacity. The study is led by Professor Johnny Ludvigsson at Linköping University, Sweden. The first patient was included in the study in February 2015.

  • DIAMYD®/GABA – COMBINING DIAMYD® WITH GABA
  • Intervention study
    A placebo-controlled study, where Diamyd® is being tested in combination with GABA. The study comprises 75 patients between the ages of 4 and 18 recently diagnosed with type 1 diabetes, and will continue for a total of 12 months. The aim of the combination treatment is to preserve the body’s residual capacity to produce insulin. The study is led by Professor Kenneth McCormick at the University of Alabama at Birmingham, USA. The first patient was included in the study in March 2015.

  • EDCR IIa – COMBINING DIAMYD® WITH ETANERCEPT AND VITAMIN D
  • Intervention study
    An open label study, where Diamyd® is combined with etanercept and vitamin D. The study comprises 20 patients between the ages of 8 and 18 who have been newly diagnosed with type 1 diabetes, and will continue for a total of 30 months. The aim of the study is to evaluate the safety of the combination treatment and the effect on the immune system and the patients’ insulin producing capacity. The study is led by Professor Johnny Ludvigsson at Linköping University, Sweden. The first patient was included in the study in May 2015.

  • DiAPREV-IT 1 – DIAMYD®
  • Prevention (interception) study
    A placebo-controlled study, where Diamyd® is being tested in children at high risk of developing type 1 diabetes, meaning that they have been found to have an ongoing autoimmune process but do not yet have any clinical symptoms of diabetes. A total of 50 participants from the age of 4 have been enrolled in the study, which will continue for five years. The aim of the study is to evaluate whether Diamyd® can delay or prevent the participants from presenting with type 1 diabetes. The study is led by Dr. Helena Elding Larsson at Lund University, Sweden. Five year results are expected at the end of 2016.

  • DiAPREV-IT 2 – COMBINING DIAMYD® WITH VITAMIN D
  • Prevention (interception) study
    A placebo-controlled study, where Diamyd® is being tested in combination with vitamin D in children at high risk of developing type 1 diabetes, meaning that they have been found to have an ongoing autoimmune process but do not yet have any clinical symptoms of diabetes. A total of 80 participants between the ages of 4 and 18 will be enrolled in the study, which will last for five years. The aim of the study is to evaluate whether Diamyd® can delay or prevent the participants from presenting with type 1 diabetes. The study is led by Dr. Helena Elding Larsson at Lund University, Sweden. The first patient was included in March 2015.