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

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Andromeda Biotech Ltd.
ClinicalTrials.gov Identifier:
NCT00615264
First received: February 4, 2008
Last updated: September 14, 2011
Last verified: September 2011
History of Changes
  Purpose

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
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, 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:

U.S. FDA Resources

Further study details as provided by Andromeda Biotech Ltd.:

Primary Outcome Measures:
  • Stimulated C-peptide, as determined by change from baseline in C-peptide AUC measured in a 20 minutes glucagon-stimulated test (GST) [ Time Frame: 0, to 24 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Percent of patients that achieve HbA1c=<7% [ Time Frame: 0, 3, 6, 9, 12, 15, 18, 21, 24 ] [ Designated as safety issue: No ]
  • mixed-meal stimulated C-peptide secretion, as measured bychange in AUC from baseline to 24 months [ Time Frame: 0, 6, 12, 18, 24 ] [ Designated as safety issue: No ]
  • Fasting C-peptide, as measured by change from baseline to 24 months. [ Time Frame: 24 months ] [ Designated as safety issue: No ]

Enrollment: 457
Study Start Date: September 2005
Estimated Study Completion Date: December 2011
Estimated Primary Completion Date: September 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1
DiaPep277 1.0 mg + 40 mg Mannitol in 0.5ml 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: 2
Mannitol 40 mg in 0.5ml lipid emulsion.
 Drug: Placebo
Mannitol (excipient) 40 mg, administered as subcutaneous injection on 1, 3, 6, 9, 12, 15, 18 and 21 months.

  Eligibility

Ages Eligible for Study:   16 Years to 45 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
Please refer to this study by its ClinicalTrials.gov identifier: NCT00615264

  Show 34 Study Locations
Sponsors and Collaborators
Andromeda Biotech Ltd.
Investigators
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

No publications provided

Responsible Party: Andromeda Biotech Ltd.
ClinicalTrials.gov Identifier: NCT00615264     History of Changes
Other Study ID Numbers: 901, ISRCTN55429664
Study First Received: February 4, 2008
Last Updated: September 14, 2011
Health Authority: Austria: Federal Ministry for Health and Women
Czech Republic: State Institute for Drug Control
Finland: Finnish Medicines Agency
Germany: Federal Institute for Drugs and Medical Devices
Greece: National Organization of Medicines
Israel: The Israel National Institute for Health Policy Research and Health Services Research
Italy: Ministry of Health
South Africa: Medicines Control Council
Spain: Spanish Agency of Medicines
United Kingdom: Medicines and Healthcare Products Regulatory Agency
United States: Food and Drug Administration

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 1
Glucose Metabolism Disorders
Metabolic Diseases
 Endocrine System Diseases
Autoimmune Diseases
Immune System Diseases

ClinicalTrials.gov processed this record on May 16, 2013