Efficacy and Safety Study of DiaPep277 in Newly Diagnosed Type 1 Diabetes Adults

• Status: Completed
• Trial end date: 2014-10-01
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Andromeda Biotech Ltd.

Criteria

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