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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

February 4, 2008
May 25, 2016
September 2005
September 2011   (final data collection date for primary outcome measure)
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.
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
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.
  • 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: DiaPep277
    DiaPep277 1.0 mg + 40 mg Mannitol in 0.5 mL lipid emulsion.
    Intervention: Drug: DiaPep277
  • Placebo Comparator: Placebo
    Mannitol 40 mg in 0.5 mL 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   (Child, Adult)
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
Not Provided
Not Provided
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.
May 2016

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