A Phase III Study to Investigate the Impact of Diamyd in Patients Newly Diagnosed With Type 1 Diabetes (EU)

• Status: Terminated
• Trial end date: 2011-08-01
• Target enrollment: 0
• Participant gender: All

Summary

The purpose of this study is to determine whether Diamyd (rhGAD65 formulated in alum) is effective in preserving the body's own insulin producing capacity in patients recently diagnosed with type 1 diabetes.

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

Details

• Lead Sponsor: Diamyd Therapeutics AB
• Treatments: Aluminum sulfate

Criteria

Main Inclusion Criteria:

• Male and female patients between 10 and 20 years of age

• Insulin dependent type 1 diabetes mellitus diagnosed within the previous 3 months at time of screening

• Fasting C-peptide level at time of screening above 0.1 nmol/L

• Elevated GAD65 antibodies (GADA) at time of screening

Main Exclusion Criteria:

• Treatment with immunosuppressants or any anti-diabetic medications other than insulin

• A history of certain diseases or conditions (e.g. anemia, HIV, hepatitis, epilepsy, head trauma, neurological diseases or cerebrovascular accident, alcohol or drug abuse etc)

• Treatment with any vaccine within 1 month prior to planned first Diamyd dose or planned treatment with vaccine up to 2 months after the last injection with Diamyd, excluding the influenza vaccine

• Participation in other clinical trials with a new chemical entity within the previous 3 months

• Pregnancy or planned pregnancy within 1 year after the last Diamyd dose

• Presence of associated serious disease or condition which in the opinion of the investigator makes the patient non-eligible for the study