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
  Purpose

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.


Condition Intervention Phase
Type 1 Diabetes Mellitus
Drug: DiaPep277
Drug: Placebo
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/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 and Safety of DiaPep277 in Newly Diagnosed Type 1 Diabetes Subjects

Resource links provided by NLM:


Further study details as provided by Andromeda Biotech Ltd.:

Primary Outcome Measures:
  • 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 ]

Secondary Outcome Measures:
  • Percent of subjects that achieve good glycemic control: HbA1c<7% [ Time Frame: 25 months ] [ Designated as safety issue: Yes ]

Other Outcome Measures:
  • 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 ]

Estimated Enrollment: 450
Study Start Date: April 2010
Estimated Study Completion Date: December 2013
Estimated Primary Completion Date: October 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: DiaPep277 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


  Eligibility

Ages Eligible for Study:   20 Years to 45 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01103284

  Show 75 Study Locations
Sponsors and Collaborators
Andromeda Biotech Ltd.
Investigators
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
  More Information

Additional Information:
Publications:

Responsible Party: Andromeda Biotech Ltd.
ClinicalTrials.gov Identifier: NCT01103284     History of Changes
Other Study ID Numbers: DiaPep277-1001
Study First Received: April 13, 2010
Last Updated: July 10, 2013
Health Authority: United States: Food and Drug Administration
Canada: Health Canada
Israel: Ethics Commission

Keywords provided by Andromeda Biotech Ltd.:
beta-cells
autoimmune
Diabetes
immunomodulation

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 April 17, 2014