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

NCT ID: NCT01898286

Last Updated: 2016-05-26

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: PHASE3
• Total Enrollment: 38 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2013-10-31
• Study Completion Date: 2014-12-31

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®.

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.

Conditions

Type 1 Diabetes

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

DiaPep277®

Administration of DiaPep277® to patients previously enrolled in the Phase 3 Study 1001 (NCT01103284)

Group Type: EXPERIMENTAL

DiaPep277®

Intervention Type: 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

Interventions

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

Intervention Type: DRUG

Eligibility 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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 47 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Andromeda Biotech Ltd.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Itamar Raz, MD

Role: PRINCIPAL_INVESTIGATOR

Hadassah Medical Center, Jerusalem

Locations

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

Countries

United States

Other Identifiers

2013-002775-17

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

1010

Identifier Type: -

Identifier Source: org_study_id