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

Phase 3TerminatedNCT01898286

Andromeda Biotech Ltd.38 enrolled

Overview

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®.

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.

Study Type

INTERVENTIONAL

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Type 1 Diabetes

Interventions

DiaPep277®DRUG

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

Eligibility

Sex: ALLMin age: 18 YearsMax age: 47 Years

Medical Language ↔ Plain English

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

Locations (3)

Atlanta Diabetes associates

Atlanta, Georgia, United States

Henry Ford Medical Centers - New Center One

Detroit, Michigan, United States

Mountain Diabetes and Endocrine Center

Asheville, North Carolina, United States

Outcomes

Primary Outcomes

Hypoglycemic Events

The number of hypoglycemic events recorded by each patient over the course of the study.

Time frame: At Early Termination Visit, Up to 25 Months

Secondary Outcomes

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.

Time frame: Baseline and Early Termination Visit, Up to 25 Months

Data from ClinicalTrials.gov

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