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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: July 10, 2013
Last verified: July 2013

February 4, 2008
July 10, 2013
September 2005
September 2011   (final data collection date for primary outcome measure)
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 ]
Stimulated C-peptide, as determined by change from baseline in C-peptide AUC measured in a 2-hour MMTT [ Time Frame: 0, 6, 12, 18, 24 months ] [ Designated as safety issue: No ]
Complete list of historical versions of study NCT00615264 on ClinicalTrials.gov Archive Site
  • 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 ]
  • Insulin daily dose required for tight glycemic control [ Time Frame: 0, 3, 6, 9, 12, 15, 18, 21, 24 ] [ Designated as safety issue: No ]
  • Rate of hypoglycemic events [ Time Frame: 0, 3, 6, 9, 12, 15, 18, 21, 24 ] [ Designated as safety issue: Yes ]
Not Provided
Not Provided
 
Efficacy Study of DiaPep277 in Newly Diagnosed Type 1 Diabetes Patients
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

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.

Not Provided
Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Type 1 Diabetes
  • Drug: DiaPep277
    1.0mg dose, administered as subcutaneous injection, on 0, 1, 3, 6, 9, 12, 15, 18 and 21 months
  • Drug: Placebo
    Mannitol (excipient) 40 mg, administered as subcutaneous injection on 1, 3, 6, 9, 12, 15, 18 and 21 months.
  • Experimental: 1
    DiaPep277 1.0 mg + 40 mg Mannitol in 0.5ml lipid emulsion.
    Intervention: Drug: DiaPep277
  • Placebo Comparator: 2
    Mannitol 40 mg in 0.5ml lipid emulsion.
    Intervention: Drug: Placebo

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
457
January 2012
September 2011   (final data collection date for primary outcome measure)

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.
Both
16 Years to 45 Years
No
Contact information is only displayed when the study is recruiting subjects
Austria,   Czech Republic,   Finland,   France,   Germany,   Greece,   Israel,   Italy,   South Africa,   Spain,   United Kingdom
 
NCT00615264
901, ISRCTN55429664
Yes
Andromeda Biotech Ltd.
Andromeda Biotech Ltd.
Not Provided
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
Andromeda Biotech Ltd.
July 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP