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Efficacy and Safety Study of DiaPep277 in Newly Diagnosed Type 1 Diabetes Adults (DIA-AID2)

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Andromeda Biotech Ltd.
ClinicalTrials.gov Identifier:
NCT01103284
First received: April 13, 2010
Last updated: July 10, 2013
Last verified: July 2013

April 13, 2010
July 10, 2013
April 2010
October 2013   (final data collection date for primary outcome measure)
beta-cell function, measured as change from baseline in stimulated C-peptide secretion (AUC) during a mixed-meal tolerance test [ Time Frame: 25 months after 1st administration ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT01103284 on ClinicalTrials.gov Archive Site
Percent of subjects that achieve good glycemic control: HbA1c<7% [ Time Frame: 25 months ] [ Designated as safety issue: Yes ]
Same as current
  • daily insulin dose, adjusted to body weight (IU/kg) [ Time Frame: 25 months ] [ Designated as safety issue: No ]
  • frequency of hypoglycemic events [ Time Frame: 25 months ] [ Designated as safety issue: Yes ]
Not Provided
 
Efficacy and Safety Study of DiaPep277 in Newly Diagnosed Type 1 Diabetes Adults
A Phase 3, Multinational, Randomized, Double-Blind, Placebo-Controlled, Parallel-Group Study to Investigate the Clinical and Safety of DiaPep277 in Newly Diagnosed Type 1 Diabetes Subjects

This study will look at the treatment effect of DiaPep277 on preservation of beta-cell function, as defined by meal-stimulated secretion of insulin. DiaPep277 is a peptide that changes the way the immune system behaves, stopping its attack on the beta-cells.

Adults (>20 years) with newly diagnosed (<6 months) type 1 diabetes will be treated with 10 injections of DiaPep277 or Placebo over a 2-year treatment and follow-up period.

Not Provided
Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Type 1 Diabetes Mellitus
  • Drug: DiaPep277
    1.0 mg dose, administered as subcutaneous injection. Dosing schedule: 0, 1, 3, 6, 9, 12, 15, 18, 21, 24 months
  • Drug: Placebo

    40 mg mannitol, administered subcutaneously,

    Dosing: 0, 1, 3, 6, 9, 12, 15, 18, 21, 24 months

Experimental: DiaPep277
Interventions:
  • Drug: DiaPep277
  • Drug: Placebo

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
450
December 2013
October 2013   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • clinical diagnosis of type 1 diabetes within last 6 months
  • Age 20-45 years
  • fasting basal C-peptide equal or greater than 0.22nmol/L, lower than 0.8nmol/L
  • BMI between 17 and 30 at screening

Exclusion Criteria:

  • Significant disease or condition other than type 1 diabetes
  • Diabetes-related complications
  • Ongoing treatment with immunosuppressive or immunomodulating agents including chronic corticosteroids
Both
20 Years to 45 Years
No
Contact information is only displayed when the study is recruiting subjects
United States,   Austria,   Belarus,   Canada,   Czech Republic,   Finland,   Germany,   Hungary,   Israel,   Italy,   Lithuania,   Poland,   Russian Federation,   Spain
 
NCT01103284
DiaPep277-1001
Yes
Andromeda Biotech Ltd.
Andromeda Biotech Ltd.
Not Provided
Principal Investigator: Itamar Raz, MD Hadassah Medical Center, Jerusalem
Principal Investigator: Thomas Linn, MD Justus-Liebig-University Giessen
Principal Investigator: Paolo P Pozzilli, MB, BS, MD University Campus Bio-Medico, Rome
Principal Investigator: Philip Raskin, MD UT Southwestern Medical Center, Dallas
Andromeda Biotech Ltd.
July 2013

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