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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Andromeda Biotech Ltd.
ClinicalTrials.gov Identifier:
NCT00615264
First received: February 4, 2008
Last updated: May 25, 2016
Last verified: May 2016
  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:


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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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.

  Eligibility

Ages Eligible for Study:   16 Years to 45 Years   (Child, Adult)
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Andromeda Biotech Ltd.
ClinicalTrials.gov Identifier: NCT00615264     History of Changes
Other Study ID Numbers: 901  ISRCTN55429664 
Study First Received: February 4, 2008
Results First Received: November 16, 2015
Last Updated: May 25, 2016
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
Mannitol
Diuretics, Osmotic
Diuretics
Natriuretic Agents
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on September 30, 2016