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

A Phase III, 3-Arm, Randomized, Double-Blind, Placebo-Controlled, Multicenter Study to Investigate the Impact of Diamyd on the Progression of Diabetes in Patients Newly Diagnosed With Type 1 Diabetes Mellitus (USA)

The intended purpose of this study was 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.

Based on results from other clinical trials with the study drug it was judged unlikely this study would meet the intended primary or secondary efficacy endpoints. Therefore the primary focus of this study was changed to ensure that safety data was available for at least 6 months following the last dose of active study drug. Thereafter the study was terminated.

Main Inclusion Criteria:

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

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