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Completed

NCT Number: NCT00644501

Long-Term Treatment Effect of DiaPep277 in Type 1 Diabetes

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.

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Key information

Conditions

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

Age range

18 year–48 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Wolfson Medical Centre, Holon, Israel

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

DiaPep277

Drug

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.

Primary outcomes

  1. 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

Secondary outcomes

  1. improved metabolic control and the insulin dose required to maintain it.

    Time frame: every 3 months up to 24 months from T0

Sponsors and collaborators

Lead sponsor

Andromeda Biotech Ltd.

Industry

Registry information

Official study title

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

Important dates

Study start
2008
Primary completion
2013
Study completion
2013
First posted
Mar 26, 2008
Registry last updated
Jul 11, 2013

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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