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Long-Term Treatment Effect of DiaPep277 in Type 1 Diabetes

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00644501
Recruitment Status : Completed
First Posted : March 26, 2008
Last Update Posted : July 11, 2013
Information provided by (Responsible Party):
Andromeda Biotech Ltd.

Brief Summary:
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 or disease Intervention/treatment Phase
Type 1 Diabetes Drug: DiaPep277 Phase 3

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 43 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (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)
Study Start Date : September 2008
Actual Primary Completion Date : May 2013
Actual Study Completion Date : June 2013

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Diabetes Type 1

Arm Intervention/treatment
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.

Primary Outcome Measures :
  1. 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 ]

Secondary Outcome Measures :
  1. improved metabolic control and the insulin dose required to maintain it. [ Time Frame: every 3 months up to 24 months from T0 ]

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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Ages Eligible for Study:   18 Years to 48 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00644501

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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.
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Principal Investigator: Itamar Raz, MD Hadassah Medical Center
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Responsible Party: Andromeda Biotech Ltd. Identifier: NCT00644501    
Other Study ID Numbers: 910
First Posted: March 26, 2008    Key Record Dates
Last Update Posted: July 11, 2013
Last Verified: July 2013
Keywords provided by Andromeda Biotech Ltd.:
type 1 diabetes
beta cells
Additional relevant MeSH terms:
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Diabetes Mellitus, Type 1
Diabetes Mellitus
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Autoimmune Diseases
Immune System Diseases