Type 1 Diabetes Mellitus Clinical Trial
Official title:
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.
n/a
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment
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