A Phase 3, Multinational, Randomized, Double-Blind, Placebo-Controlled, Parallel-Group Study to Investigate the Clinical and Safety of DiaPep277 in Newly Diagnosed Type 1 Diabetes Subjects
| City: |
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Orlando |
| State: |
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Florida |
| Zip Code: |
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32825 |
| Conditions: |
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Type 1 Diabetes Mellitus |
| Purpose: |
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This study will look at the treatment effect of DiaPep277 on preservation of beta-cell
function, as defined by meal-stimulated secretion of insulin. DiaPep277 is a peptide that
changes the way the immune system behaves, stopping its attack on the beta-cells.
Adults (>20 years) with newly diagnosed (<6 months) type 1 diabetes will be treated with 10
injections of DiaPep277 or Placebo over a 2-year treatment and follow-up period.
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| Study Summary: |
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| Criteria: |
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Inclusion Criteria:
- clinical diagnosis of type 1 diabetes within last 6 months
- Age 20-45 years
- fasting basal C-peptide equal or greater than 0.22nmol/L, lower than 0.8nmol/L
- BMI between 17 and 30 at screening
Exclusion Criteria:
- Significant disease or condition other than type 1 diabetes
- Diabetes-related complications
- Ongoing treatment with immunosuppressive or immunomodulating agents including
chronic corticosteroids
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| NCT ID: |
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NCT01103284 |
| Primary Contact: |
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Principal Investigator
Itamar Raz, MD
Hadassah Medical Center, Jerusalem
Merana Tamir, Ph.D.
Phone: +972 8 9387730
Email: merana@andromedabio.com
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| Backup Contact: |
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N/A |
| Location Contact: |
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Orlando, Florida 32825
United States
Site Status: Recruiting |
| Data Source: |
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ClinicalTrials.gov |
| Date Processed: |
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May 22, 2013 |
| Modifications to this listing: |
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