Open-Label Extension Study to Evaluate Long Term Safety and Treatment Effect of DiaPep277®
| Status: | Not yet recruiting |
|---|---|
| Conditions: | Diabetes |
| Therapuetic Areas: | Endocrinology |
| Healthy: | No |
| Age Range: | 18 - 47 |
| Updated: | 4/2/2016 |
| Start Date: | September 2013 |
| End Date: | January 2017 |
| Contact: | Merana Tamir, Ph.D |
| Email: | merana@andromedabio.com |
| Phone: | +972-8-938777 |
Open-Label Study to Evaluate Long Term Safety and Treatment Effect of DiaPep277® in Subjects Who Have Completed Study 1001
Treatment with DiaPep277® is expected to be long-term; stopping treatment may result in the
eventual loss of the preserved beta-cell function. Indeed, extension of phase 2 studies has
shown that patients who were initially treated with DiaPep277® and maintained their initial
beta-cell function, required continuation of treatment, losing beta-cell function if
switched to Placebo. These extension studies were too small for the outcome to be
statistically significant, but they suggested that continuation of treatment is needed for
long-term maintenance of efficacy.
Therefore, in this extension study, patients who complete the 1001 phase 3 study and
maintain clinically significant beta-cell function are offered a 2-year continuation of
active treatment, since they are likely to benefit from use of the medication. The
participation in the extension study will be offered to all eligible subjects who complete
the 1001 study, regardless of the treatment arm allocation in the initial study.
By achieving long-term preservation of beta-cell function, patients are expected to maintain
good management of the disease, manifesting as better glycemic control and fewer
hypoglycemic events.
eventual loss of the preserved beta-cell function. Indeed, extension of phase 2 studies has
shown that patients who were initially treated with DiaPep277® and maintained their initial
beta-cell function, required continuation of treatment, losing beta-cell function if
switched to Placebo. These extension studies were too small for the outcome to be
statistically significant, but they suggested that continuation of treatment is needed for
long-term maintenance of efficacy.
Therefore, in this extension study, patients who complete the 1001 phase 3 study and
maintain clinically significant beta-cell function are offered a 2-year continuation of
active treatment, since they are likely to benefit from use of the medication. The
participation in the extension study will be offered to all eligible subjects who complete
the 1001 study, regardless of the treatment arm allocation in the initial study.
By achieving long-term preservation of beta-cell function, patients are expected to maintain
good management of the disease, manifesting as better glycemic control and fewer
hypoglycemic events.
Inclusion Criteria:
- patients with type 1 diabetes who participated in the 1001 study
- residual beta-cell function demonstrated by stimulated C-peptide ≥ 0.20nmol/l.
Exclusion Criteria:
- The subject has any significant ongoing diseases or conditions that is likely to
affect the subject's response to treatment
- The subject has a history of any kind of malignant tumor.
- The subject has clinical evidence of any diabetes-related complication
- Subject has history of endogenous allergic reactivity:
- The subject has a known immune deficiency
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