Open-Label Extension Study to Evaluate Long Term Safety and Treatment Effect of DiaPep277®

Study Overview
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Brief Summary
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This is an extension study to evaluate the safety and tolerability of long-term treatment with DiaPep277® and to determine the long-term treatment effect of DiaPep277® on parameters of metabolic control and on preservation of beta-cell function in subjects who have long exposure to DiaPep277®.

Detailed Description
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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 (NCT01103284) 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.

Official Title
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Open-Label Study to Evaluate Long Term Safety and Treatment Effect of DiaPep277® in Subjects Who Have Completed Study 1001 (NCT01103284)

Conditions
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Type 1 Diabetes

Intervention / Treatment
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* Drug: DiaPep277®


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: patients with type 1 diabetes who participated in the 1001 study residual beta-cell function demonstrated by stimulated C-peptide ≥ 0.20 nmol/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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 47 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: DiaPep277®<br>Administration of DiaPep277® to patients previously enrolled in the Phase 3 Study 1001 (NCT01103284) | Drug: DiaPep277®<br>* 1 mg of DiaPep277® subcutaneously in the upper arm at 0, 3, 6, 9, 12, 15, 18, and 21 months, for a total of 8 administrations<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Hypoglycemic Events | The number of hypoglycemic events recorded by each patient over the course of the study. | At Early Termination Visit, Up to 25 Months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change From Baseline in Glucagon-stimulated C-peptide AUC at Early Termination Visit | Beta-cell function, measured as change in stimulated C-peptide secretion measured 0, 2, 6, 10 and 20 minutes post administration [area under the curve (AUC), 0-20 minutes] at Baseline and the early termination visit (up to 25 months), during a glucagon stimulation test (GST). Change was calculated for each patient by subtracting the baseline AUC value (defined as the last non-missing assessment prior to first dose in the 1010 study but after the end of study 1001) from the early termination visit AUC. | Baseline and Early Termination Visit, Up to 25 Months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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immune modulation of type 1 diabetes, immune intervention in type 1 diabetes, C peptide, beta cell function