Open-Label Extension Study to Evaluate Long Term Safety and Treatment Effect of DiaPep277® (DIA-AID 2)

Study Description

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Brief Summary:

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®.

Condition or disease	Intervention/treatment	Phase
Type 1 Diabetes	Drug: DiaPep277®	Phase 3

Detailed Description:

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 Design

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Study Type :	Interventional (Clinical Trial)
Actual Enrollment :	38 participants
Intervention Model:	Single Group Assignment
Masking:	None (Open Label)
Primary Purpose:	Treatment
Official Title:	Open-Label Study to Evaluate Long Term Safety and Treatment Effect of DiaPep277® in Subjects Who Have Completed Study 1001 (NCT01103284)
Study Start Date :	October 2013
Actual Primary Completion Date :	September 2014
Actual Study Completion Date :	December 2014

Arms and Interventions

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Arm	Intervention/treatment
Experimental: DiaPep277®; Administration of DiaPep277® to patients previously enrolled in the Phase 3 Study 1001 (NCT01103284)	Drug: DiaPep277®; 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

Outcome Measures

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Primary Outcome Measures :

1. Hypoglycemic Events [ Time Frame: At Early Termination Visit, Up to 25 Months ]
   The number of hypoglycemic events recorded by each patient over the course of the study.

Secondary Outcome Measures :

1. Change From Baseline in Glucagon-stimulated C-peptide AUC at Early Termination Visit [ Time Frame: Baseline and Early Termination Visit, Up to 25 Months ]
   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.

Other Outcome Measures:

1. Change From Baseline in Daily Insulin Dose, Per kg Body Weight, at Early Termination Visit [ Time Frame: Baseline and Early Termination Visit, up to 25 months ]
2. Glycemic Control (Change From Baseline in % HbA1c) [ Time Frame: Baseline and Early Termination Visit, Up to 25 Months ]

Eligibility Criteria

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Ages Eligible for Study:	18 Years to 47 Years (Adult)
Sexes Eligible for Study:	All
Accepts Healthy Volunteers:	No

Criteria

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

Contacts and Locations

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Locations

United States, Georgia
Atlanta Diabetes associates
Atlanta, Georgia, United States, 30318
United States, Michigan
Henry Ford Medical Centers - New Center One
Detroit, Michigan, United States, 48202
United States, North Carolina
Mountain Diabetes and Endocrine Center
Asheville, North Carolina, United States, 28803

Sponsors and Collaborators

Andromeda Biotech Ltd.

Investigators

Principal Investigator:	Itamar Raz, MD	Hadassah Medical Center, Jerusalem

More Information

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Responsible Party:	Andromeda Biotech Ltd.
ClinicalTrials.gov Identifier:	NCT01898286 History of Changes
Other Study ID Numbers:	1010; 2013-002775-17 ( EudraCT Number )
First Posted:	July 12, 2013
Results First Posted:	May 26, 2016
Last Update Posted:	May 26, 2016
Last Verified:	April 2016

Keywords provided by Andromeda Biotech Ltd.:

C peptide; beta cell function; immune modulation of type 1 diabetes; immune intervention in type 1 diabetes

Additional relevant MeSH terms:

Diabetes Mellitus, Type 1; Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases	Endocrine System Diseases; Autoimmune Diseases; Immune System Diseases