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Completed

NCT Number: NCT00615264

Efficacy Study of DiaPep277 in Newly Diagnosed Type 1 Diabetes Patients

The purpose of this study is to determine if DiaPep277 can effectively protect the internal production of insulin in patients newly diagnosed with type 1 diabetes, by stopping the immune destruction of insulin-producing beta-cells in the pancreas. DiaPep277 acts on the immune system and is expected to prevent further destruction of the beta-cells by stimulating regulatory responses, without causing immunological suppression.

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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

16 year–45 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Rudolfstiftung Hospital, Vienna, Austria

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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 diagnosis of type 1 diabetes for up to 3 months at screening
  • Insulin dependency
  • Fasting C-peptide levels >= 0.22 nmol/L
  • Presence of at least 1 of the diabetes-related autoantibodies (IA-2A, GAD or IA)

Exclusion criteria

  • Pregnancy or intent to conceive in the next 2 years
  • Significant diseases that could affect response to treatment, such as tumors, psychiatric disorders, substance abuse, severe allergies or diabetes-related complications.
  • Patient has immune deficiency or receives immuno-suppressive or cytotoxic drugs.

Treatment and study plan

DiaPep277

Drug

1.0mg dose, administered as subcutaneous injection, on 0, 1, 3, 6, 9, 12, 15, 18 and 21 months

Placebo

Drug

Mannitol (excipient) 40 mg, administered as subcutaneous injection on 1, 3, 6, 9, 12, 15, 18 and 21 months.

Primary outcomes

  1. Change From Baseline in Glucagon-stimulated C-peptide AUC at 24 Months

    Time frame: Baseline and 24 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 24 months, during a glucagon stimulation test (GST). The change in AUC was calculated per patient by subtracting the baseline AUC from the 24 month AUC.

Secondary outcomes

  1. Change From Baseline in Mixed-meal Stimulated C-peptide AUC at 24 Months

    Time frame: Baseline and 24 Months

    Beta cell function, measured as stimulated C-peptide secretion from 0 to 120 min post administration AUC, at baseline and 24 month measurements in a mixed-meal tolerance test (MMTT). The change in AUC was calculated per patient by subtracting the baseline AUC from the 24 month AUC.

Sponsors and collaborators

Lead sponsor

Andromeda Biotech Ltd.

Industry

Registry information

Official study title

A Phase 3, Multinational, Randomized, Double-Blind, Placebo-Controlled, Parallel-Group Study To Investigate The Clinical Efficacy And Safety of DiaPep277® in Newly Diagnosed Type 1 Diabetes Patients

Acronym: DIA-AID

Important dates

Study start
2005
Primary completion
2011
Study completion
2012
First posted
Feb 14, 2008
Registry last updated
Jun 6, 2016

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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