Efficacy and Safety Study of DiaPep277 in Newly Diagnosed Type 1 Diabetes Adults
Efficacy and Safety Study of DiaPep277 in Newly Diagnosed Type 1 Diabetes Adults
This study will look at the treatment effect of DiaPep277 on preservation of beta-cell
 function, as defined by meal-stimulated secretion of insulin. DiaPep277 is a peptide that
 changes the way the immune system behaves, stopping its attack on the beta-cells.

 Adults (>20 years) with newly diagnosed (<6 months) type 1 diabetes will be treated with 10
 injections of DiaPep277 or Placebo over a 2-year treatment and follow-up period.
Inclusion Criteria:

 -  clinical diagnosis of type 1 diabetes within last 6 months

 -  Age 20-45 years

 -  fasting basal C-peptide equal or greater than 0.22 nmol/L, lower than 0.8 nmol/L

 -  BMI between 17 and 30 at screening

 Exclusion Criteria:

 -  Significant disease or condition other than type 1 diabetes

 -  Diabetes-related complications

 -  Ongoing treatment with immunosuppressive or immunomodulating agents including chronic
 corticosteroids