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news.Company is conducting a global phase III program with its diabetes vaccine, Diamyd in nine European countries and the US
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Diamyd Medical has reported that 90% of the total 320 children and adolescents with type 1 diabetes for the European phase III study with the diabetes vaccine – Diamyd, have now been included and have received injections of Diamyd or placebo.
Reportedly, the company is conducting a global phase III program with the diabetes vaccine, Diamyd, comprising a study in nine countries in Europe and a study in the US. In each study, 320 children and adolescents aged 10-20 newly diagnosed with type 1 diabetes will take part.
The purpose of the study is to investigate whether the Diamyd vaccine can delay or stop the break-down of beta cells in the pancreas and hence preserve the body’s own ability to control the blood sugar in patients newly diagnosed with type 1 diabetes. This could in turn reduce the risk for acute and long-term diabetic complications.
The company said that in the study, two-thirds of participants are receiving the Diamyd vaccine and one-third is receiving placebo. The study is conducted at 70 clinics in Europe.
Elisabeth Lindner, president and CEO of Diamyd Medical, said: “We are now close to our first important milestone in the phase III program. We expect the study to be fully recruited by November 2009. The results will be analyzed during spring 2011, when all patients have participated in the study for 15 months.”