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

NCT01103284 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 475

Last updated 2016-05-26

Study results available
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Summary

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.

Conditions

  • Type 1 Diabetes Mellitus

Interventions

DRUG

DiaPep277

1.0 mg dose in 0.5 mL of solution

DRUG

Placebo

40 mg mannitol in 0.5 mL of solution. Dosing: 0, 1, 3, 6, 9, 12, 15, 18, 21, 24 months

Sponsors & Collaborators

  • Andromeda Biotech Ltd.

    lead INDUSTRY

Principal Investigators

  • Itamar Raz, MD · Hadassah Medical Center, Jerusalem

  • Thomas Linn, MD · University of Giessen

  • Paolo P Pozzilli, MB, BS, MD · University Campus Bio-Medico, Rome

  • Philip Raskin, MD · UT Southwestern Medical Center, Dallas

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
20 Years
Max Age
45 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2010-04-30
Primary Completion
2014-10-31
Completion
2014-10-31

Countries

  • United States
  • Austria
  • Belarus
  • Canada
  • Czechia
  • Finland
  • Germany
  • Hungary
  • Israel
  • Italy
  • Lithuania
  • Poland
  • Russia
  • Spain

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01103284 on ClinicalTrials.gov