The EU Phase III study is a multinational, multicenter, double-blind, randomized, placebo-controlled trial enrolling approximately 320 patients between 10 and 20 years of age who have been diagnosed with type 1 diabetes within three months. The study is being conducted at more than 60 clinics in nine European countries, i.e. Finland, France, Germany, Holland, Italy, Slovenia, Spain, Sweden and UK. One third of the patients received four injections with Diamyd?®, one third received two injections with Diamyd?® followed by two injections with placebo, and one third has received four injections with placebo. The injections were given on Day one, and then after one month, three months and nine months.

In its global Phase III program, Diamyd is also conducting a similar study in the U.S., DiaPrevent, which was fully enrolled in December 2010. Diamyd expects to complete the main study period of this study during the spring of 2012.

The global Phase III program aims to investigate whether Diamyd?® can halt or slow the destruction of beta cells in the pancreas in type 1 diabetes, preserving the beta cell function and the body's own ability to control the blood sugar level. This in turn reduces the risk of both short and long term diabetes complications. In Phase II studies, the Diamyd?® therapy has been shown to slow the loss of beta cell function compared to placebo.

The two studies have now enrolled more than 640 recently diagnosed type 1 diabetes patients between 10 and 20 years of age in Europe and USA.

Source: Diamyd Medical