DIAMYD ANNOUNCES RESULTS OF DIABETES DRUG PHASE II TRIAL

Diamyd Medical has announced that its lead drug candidate, Diamyd, has demonstrated statistically significant efficacy in preserving insulin production in a Phase II clinical trial in 70 children and adolescents with Type 1 diabetes.

The results demonstrate that the group of 35 recently diagnosed Type 1 diabetes patients who received Diamyd produced approximately twice as much meal-stimulated insulin (as measured by the C-peptide) 15 months after the first treatment compared with the placebo group. Preserving insulin-production is crucial for delaying the complications associated with long-term diabetes.

The ability of the beta cells to produce insulin in response to a meal is considered to be the key factor when it comes to assessing beta cell function. As insulin and C-peptide are produced in equal amounts, and C-peptide is easier to measure, meal stimulated C-peptide levels are an important parameter in diabetes studies where the aim is to preserve beta cell function. The C-peptide production in both groups experienced a decline, but the decline was significantly less in the Diamyd group. There were no significant differences in fasting C-peptide levels between the two groups. The treatment itself consisted of two 20-mg injections of Diamyd, one at day one and one at day 30.