Type 1 Diabetes Mellitus Clinical Trial
Official title:
A Phase 3, Multinational, Randomized, Double-Blind, Placebo-Controlled, Parallel-Group Study to Investigate the Clinical and Safety of DiaPep277 in Newly Diagnosed Type 1 Diabetes Subjects
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.
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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