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Efficacy Study of DiaPep277 in Newly Diagnosed Type 1 Diabetes Patients (DIA-AID)

This study has been completed.
Information provided by (Responsible Party):
Andromeda Biotech Ltd. Identifier:
First received: February 4, 2008
Last updated: May 25, 2016
Last verified: May 2016
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.

Condition Intervention Phase
Type 1 Diabetes
Drug: DiaPep277
Drug: Placebo
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official 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

Resource links provided by NLM:

Further study details as provided by Andromeda Biotech Ltd.:

Primary Outcome Measures:
  • 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 Outcome Measures:
  • 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.

Enrollment: 457
Study Start Date: September 2005
Study Completion Date: January 2012
Primary Completion Date: September 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: DiaPep277
DiaPep277 1.0 mg + 40 mg Mannitol in 0.5 mL lipid emulsion.
Drug: DiaPep277
1.0mg dose, administered as subcutaneous injection, on 0, 1, 3, 6, 9, 12, 15, 18 and 21 months
Placebo Comparator: Placebo
Mannitol 40 mg in 0.5 mL lipid emulsion.
Drug: Placebo
Mannitol (excipient) 40 mg, administered as subcutaneous injection on 1, 3, 6, 9, 12, 15, 18 and 21 months.


Ages Eligible for Study:   16 Years to 45 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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.
  Contacts and Locations
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Please refer to this study by its identifier: NCT00615264

  Show 34 Study Locations
Sponsors and Collaborators
Andromeda Biotech Ltd.
Principal Investigator: Itamar Raz, MD Hadassah Medical Center, Jerusalem
Principal Investigator: Paolo Pozzilli, MD Universita Campus Bio-Medico, Rome
Principal Investigator: Francois Bonici, MD New Groote Schuur Hospital, Cape Town
Principal Investigator: Thomas Linn, MD Universitätsklinikum, Giessen
  More Information

Publications automatically indexed to this study by Identifier (NCT Number):
Responsible Party: Andromeda Biotech Ltd. Identifier: NCT00615264     History of Changes
Other Study ID Numbers: 901
Study First Received: February 4, 2008
Results First Received: November 16, 2015
Last Updated: May 25, 2016

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 1
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Autoimmune Diseases
Immune System Diseases
Diuretics, Osmotic
Natriuretic Agents
Physiological Effects of Drugs processed this record on May 25, 2017