Back to resultsLong-Term Treatment Effect of DiaPep277 in Type 1 Diabetes
Primary Purpose
Type 1 Diabetes
Status
Completed
Phase
Phase 3
Locations
Israel
Study Type
Interventional
Intervention
DiaPep277
Sponsored by
About this trial
This is an interventional treatment trial for Type 1 Diabetes focused on measuring type 1 diabetes, beta cells, immunomodulation, immunointervention
Eligibility 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.
Sites / Locations
- Wolfson Medical Centre
- Diabetic Unit, Hadassah Medical Center
- Schneider Children's Medical Centre
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
1
Arm Description
Outcomes
Primary Outcome Measures
Preservation of endogenous insulin secretion/beta-cell function, as measured by mixed-meal tolerance test stimulated C-peptide secretion.
Secondary Outcome Measures
improved metabolic control and the insulin dose required to maintain it.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00644501
Brief Title
Long-Term Treatment Effect of DiaPep277 in Type 1 Diabetes
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 Type
Interventional
2. Study Status
Record Verification Date
July 2013
Overall Recruitment Status
Completed
Study Start Date
September 2008 (undefined)
Primary Completion Date
May 2013 (Actual)
Study Completion Date
June 2013 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Andromeda Biotech Ltd.
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Type 1 Diabetes
Keywords
type 1 diabetes, beta cells, immunomodulation, immunointervention
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
43 (Actual)
8. Arms, Groups, and Interventions
Arm Title
1
Arm Type
Experimental
Intervention Type
Drug
Intervention Name(s)
DiaPep277
Intervention Description
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 Measure Information:
Title
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 Measure Information:
Title
improved metabolic control and the insulin dose required to maintain it.
Time Frame
every 3 months up to 24 months from T0
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
48 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Itamar Raz, MD
Organizational Affiliation
Hadassah Medical Organization
Official's Role
Principal Investigator
Facility Information:
Facility Name
Wolfson Medical Centre
City
Holon
ZIP/Postal Code
58100
Country
Israel
Facility Name
Diabetic Unit, Hadassah Medical Center
City
Jerusalem
ZIP/Postal Code
91120
Country
Israel
Facility Name
Schneider Children's Medical Centre
City
Petach Tikva
ZIP/Postal Code
49202
Country
Israel
12. IPD Sharing Statement
Learn more about this trial
Long-Term Treatment Effect of DiaPep277 in Type 1 Diabetes
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