NCT00644501CompletedPhase 3
Open Label Study to Evaluate Long Term Treatment Effect of DiaPep277® in Patients Who Have Completed Studies 461* (Phase II) or 901** (Pase III)
Conditions
Interventions
Drugs
Trial Snapshot
- Phase
- Phase 3
- Status
- Completed
- Sponsor
- Andromeda Biotech Ltd.
- Enrollment
- 43
- Locations
- 3
- Primary Endpoint
- Preservation of endogenous insulin secretion/beta-cell function, as measured by mixed-meal tolerance test stimulated C-peptide secretion.
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Single Group
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to 48 Years (Adult)
- Sex
- 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.
Arms & Interventions
1
Experimental
Intervention: DiaPep277 (Drug)
Outcomes
Primary Outcomes
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 Outcomes
- improved metabolic control and the insulin dose required to maintain it.(every 3 months up to 24 months from T0)
Investigators
Study Sites (3)
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