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Efficacy and Safety Study of DiaPep277 in Newly Diagnosed Type 1 Diabetes Adults


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.

Study Status: Active, not recruiting


Condition Intervention Phase
Type 1 Diabetes Mellitus Drug: DiaPep277
Drug: Placebo
Phase 3

Verified by Andromeda Biotech Ltd. July, 2013

Sponsored by: Andromeda Biotech Ltd.
Information provided by: Andromeda Biotech Ltd. identifier: NCT01103284

Study Type: Interventional

Study Design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Cleveland Clinic
Cleveland, Ohio 44195
United States

Itamar Raz, MD., Principal Investigator
Thomas Linn, MD., Principal Investigator
Paolo P Pozzilli, MB, BS, MD., Principal Investigator
Philip Raskin, MD., Principal Investigator

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