- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00644501
Long-Term Treatment Effect of DiaPep277 in Type 1 Diabetes
July 10, 2013 updated by: Andromeda Biotech Ltd.
Open Label Study to Evaluate Long Term Treatment Effect of DiaPep277® in Patients Who Have Completed Studies 461* (Phase II) or 901** (Pase III)
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 Overview
Study Type
Interventional
Enrollment (Actual)
43
Phase
- Phase 3
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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-
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Holon, Israel, 58100
- Wolfson Medical Centre
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Jerusalem, Israel, 91120
- Diabetic Unit, Hadassah Medical Center
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Petach Tikva, Israel, 49202
- Schneider Children's Medical Centre
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 48 years (ADULT)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: TREATMENT
- Allocation: NA
- Interventional Model: SINGLE_GROUP
- Masking: NONE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
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EXPERIMENTAL: 1
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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.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
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
|
every 6 months up to 24 months from T0
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
improved metabolic control and the insulin dose required to maintain it.
Time Frame: every 3 months up to 24 months from T0
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every 3 months up to 24 months from T0
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
September 1, 2008
Primary Completion (ACTUAL)
May 1, 2013
Study Completion (ACTUAL)
June 1, 2013
Study Registration Dates
First Submitted
March 20, 2008
First Submitted That Met QC Criteria
March 23, 2008
First Posted (ESTIMATE)
March 26, 2008
Study Record Updates
Last Update Posted (ESTIMATE)
July 11, 2013
Last Update Submitted That Met QC Criteria
July 10, 2013
Last Verified
July 1, 2013
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 910 (Clinical Research Center at Shands UF)
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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