Long-Term Treatment Effect of DiaPep277 in Type 1 Diabetes

July 10, 2013 updated by: Andromeda Biotech Ltd.

Open Label Study to Evaluate Long Term Treatment Effect of DiaPep277® in Patients Who Have Completed Studies 461* (Phase II) or 901** (Pase III)

The study is an open-label extension study, offering patients who participated and completed previous study 901 to continue treatment with DiaPep277 and clinical follow-up, for 2 additional years. The expectation is first to demonstrate that extended treatment with DiaPep277 is safe and second to evaluate the long-term effectiveness of treatment. Only patients who completed the previous 2-year study and still have beta-cell function above a threshold level will be eligible for this extension study.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

43

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Israel
      • Holon, Israel, 58100
        • Wolfson Medical Centre
      • Jerusalem, Israel, 91120
        • Diabetic Unit, Hadassah Medical Center
      • Petach Tikva, Israel, 49202
        • Schneider Children's Medical Centre

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 48 years (ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • A patient that participated in previous 461/PO and 901 studies and received all doses of study medication, per protocol.
  • Evidence of clinically significant residual beta-cell function demonstrated by MMTT stimulated C-peptide concentrations ≥ 0.20 nmol/L.

Exclusion Criteria:

  • The patient is pregnant or intends to become pregnant or is unwilling to use effective contraceptive method throughout the study.
  • The subject has clinical evidence of any diabetes-related complication, or severe allergy or immune deficiency.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: NA
  • Interventional Model: SINGLE_GROUP
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: 1
Drug: DiaPep277
1.0mg dose, injected subcutaneously at baseline and every 3 months thereafter (at 0, 3, 6, 9, 12, 15, 18, 21 months)for a total of 8 administrations.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Preservation of endogenous insulin secretion/beta-cell function, as measured by mixed-meal tolerance test stimulated C-peptide secretion.
Time Frame: every 6 months up to 24 months from T0
every 6 months up to 24 months from T0

Secondary Outcome Measures

Outcome Measure
Time Frame
improved metabolic control and the insulin dose required to maintain it.
Time Frame: every 3 months up to 24 months from T0
every 3 months up to 24 months from T0

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Andromeda Biotech Ltd.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 1, 2008

Primary Completion (ACTUAL)

May 1, 2013

Study Completion (ACTUAL)

June 1, 2013

Study Registration Dates

First Submitted

March 20, 2008

First Submitted That Met QC Criteria

March 23, 2008

First Posted (ESTIMATE)

March 26, 2008

Study Record Updates

Last Update Posted (ESTIMATE)

July 11, 2013

Last Update Submitted That Met QC Criteria

July 10, 2013

Last Verified

July 1, 2013

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 910 (Clinical Research Center at Shands UF)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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