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A Phase III Study to Investigate the Impact of Diamyd in Patients Newly Diagnosed With Type 1 Diabetes (USA)- DIAPREVENT - NCT00751842-14642(Clinical Trial 360804)



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City:  Rochester
State:  
NY
Zip Code: 14642
Conditions: Type 1 Diabetes Mellitus
Purpose: 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.
Study summary:
Criteria: 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
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Data Source: ClinicalTrials.gov
Date Processed: November 11, 2010
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