Efficacy and Safety Study of DiaPep277 in Newly Diagnosed Type 1 Diabetes Adults
| Status: | Completed |
|---|---|
| Conditions: | Diabetes |
| Therapuetic Areas: | Endocrinology |
| Healthy: | No |
| Age Range: | 20 - 45 |
| Updated: | 5/27/2013 |
| Start Date: | April 2010 |
| End Date: | March 2014 |
| Contact: | Merana Tamir, Ph.D. |
| Email: | merana@andromedabio.com |
| Phone: | +972 8 9387730 |
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
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.
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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