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Long-Term Treatment Effect of DiaPep277 in Type 1 Diabetes

This study is enrolling participants by invitation only.
Sponsor:
Information provided by (Responsible Party):
Andromeda Biotech Ltd.
ClinicalTrials.gov Identifier:
NCT00644501
First received: March 20, 2008
Last updated: September 14, 2011
Last verified: September 2011
History of Changes
  Purpose

The study is an open-label extension study, offering patients who participated and completed previous study 901 to continue treatment with DiaPep277 and clinical follow-up, for 2 additional years. The expectation is first to demonstrate that extended treatment with DiaPep277 is safe and second to evaluate the long-term effectiveness of treatment. Only patients who completed the previous 2-year study and still have beta-cell function above a threshold level will be eligible for this extension study.


Condition Intervention Phase
Type 1 Diabetes
 Drug: DiaPep277
 Phase 3

Study Type: Interventional
Study Design: Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Open Label Study to Evaluate Long Term Treatment Effect of DiaPep277® in Patients Who Have Completed Studies 461* (Phase II) or 901** (Pase III)

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Andromeda Biotech Ltd.:

Primary Outcome Measures:
  • Preservation of endogenous insulin secretion/beta-cell function, as measured by mixed-meal tolerance test stimulated C-peptide secretion. [ Time Frame: every 6 months up to 24 months from T0 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • improved metabolic control and the insulin dose required to maintain it. [ Time Frame: every 3 months up to 24 months from T0 ] [ Designated as safety issue: No ]

Estimated Enrollment: 50
Study Start Date: September 2008
Estimated Study Completion Date: December 2013
Estimated Primary Completion Date: August 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1 Drug: DiaPep277
1.0mg dose, injected subcutaneously at baseline and every 3 months thereafter (at 0, 3, 6, 9, 12, 15, 18, 21 months)for a total of 8 administrations.

  Eligibility

Ages Eligible for Study:   18 Years to 48 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • A patient that participated in previous 461/PO and 901 studies and received all doses of study medication, per protocol.
  • Evidence of clinically significant residual beta-cell function demonstrated by MMTT stimulated C-peptide concentrations ≥ 0.20 nmol/L.

Exclusion Criteria:

  • The patient is pregnant or intends to become pregnant or is unwilling to use effective contraceptive method throughout the study.
  • The subject has clinical evidence of any diabetes-related complication, or severe allergy or immune deficiency.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00644501

Locations
Israel
Wolfson Medical Centre
Holon, Israel, 58100
Diabetic Unit, Hadassah Medical Center
Jerusalem, Israel, 91120
Schneider Children's Medical Centre
Petach Tikva, Israel, 49202
Sponsors and Collaborators
Andromeda Biotech Ltd.
  More Information

No publications provided

Responsible Party: Andromeda Biotech Ltd.
ClinicalTrials.gov Identifier: NCT00644501     History of Changes
Other Study ID Numbers: 910
Study First Received: March 20, 2008
Last Updated: September 14, 2011
Health Authority: Israel: Ministry of Health

Keywords provided by Andromeda Biotech Ltd.:
type 1 diabetes
beta cells
immunomodulation
immunointervention

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 1
Glucose Metabolism Disorders
Metabolic Diseases
 Endocrine System Diseases
Autoimmune Diseases
Immune System Diseases

ClinicalTrials.gov processed this record on June 17, 2013