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Efficacy Study of DiaPep277 in Newly Diagnosed Type 1 Diabetes Patients

NCT00615264 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 457

Last updated 2016-06-06

Study results available
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Summary

The purpose of this study is to determine if DiaPep277 can effectively protect the internal production of insulin in patients newly diagnosed with type 1 diabetes, by stopping the immune destruction of insulin-producing beta-cells in the pancreas. DiaPep277 acts on the immune system and is expected to prevent further destruction of the beta-cells by stimulating regulatory responses, without causing immunological suppression.

Conditions

Interventions

DRUG

DiaPep277

1.0mg dose, administered as subcutaneous injection, on 0, 1, 3, 6, 9, 12, 15, 18 and 21 months

DRUG

Placebo

Mannitol (excipient) 40 mg, administered as subcutaneous injection on 1, 3, 6, 9, 12, 15, 18 and 21 months.

Sponsors & Collaborators

  • Andromeda Biotech Ltd.

    lead INDUSTRY

Principal Investigators

  • Itamar Raz, MD · Hadassah Medical Center, Jerusalem

  • Paolo Pozzilli, MD · Universita Campus Bio-Medico, Rome

  • Francois Bonici, MD · New Groote Schuur Hospital, Cape Town

  • Thomas Linn, MD · Universitätsklinikum, Giessen

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

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

Timeline & Regulatory

Start
2005-09-30
Primary Completion
2011-09-30
Completion
2012-01-31

Countries

  • Austria
  • Czechia
  • Finland
  • France
  • Germany
  • Greece
  • Israel
  • Italy
  • South Africa
  • Spain
  • United Kingdom

Study Locations

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Entities

Drugs
Diseases

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 NCT00615264 on ClinicalTrials.gov