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

Study:

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

Rationale:

n/a

Purpose:

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

Recruiting:
n/a

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.
ClinicalTrials.gov 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

This information is abridged to display results relevant only to Cleveland Clinic. To see complete record visit ClinicalTrials.gov
  Information obtained from ClinicalTrials.gov on
Link to the current ClinicalTrials.gov record.

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