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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Andromeda Biotech Ltd.
ClinicalTrials.gov Identifier:
NCT01103284
First received: April 13, 2010
Last updated: April 19, 2016
Last verified: April 2016
  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 Efficacy 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:
  • Change From Baseline in Glucagon-Stimulated C-Peptide AUC at 24 Months [ Time Frame: Baseline and 24 months ] [ Designated as safety issue: No ]
    Change in Beta-cell function, measured as stimulated C-peptide secretion 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:
  • Percentage of Subjects That Achieve Good Glycemic Control: HbA1c<7% [ Time Frame: 24 and 25 months ] [ Designated as safety issue: No ]
    The percentage of subjects achieving good glycemic control, i.e. an HbA1c <7% at study end (Month 25). If HbA1c was missing at Month 25, but the Month 24 value was available, then the Month 24 value was used to calculate the percentage of subjects with an HbA1c ≤ 7% at study end.

  • Frequency of Hypoglycemic Events [ Time Frame: Baseline to 25 Months ] [ Designated as safety issue: Yes ]
    Total number of days with at least one hypoglycemic event recorded

  • Mean Number of Days With at Least One Hypoglycemic Event [ Time Frame: Baseline to 25 months ] [ Designated as safety issue: Yes ]

Other Outcome Measures:
  • Percentage of Subjects Requiring a Daily Insulin Dose ≤ 0.5 IU/kg at End of Study [ Time Frame: 24 and 25 months ] [ Designated as safety issue: No ]
    Percentage of subjects requiring a daily insulin dose ≤ 0.5 IU/kg at end of study (25 Months). If insulin dose was missing at Month 25, but the Month 24 value was available, then the Month 24 value was used to calculate the percentage of subjects with a daily insulin dose ≤ 0.5 IU/kg at study end.


Enrollment: 475
Study Start Date: April 2010
Study Completion Date: October 2014
Primary Completion Date: October 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: DiaPep277
Administration of 1 mg DiaPep277®, subcutaneously (s.c.) in the upper arm at 0, 1, 3, 6, 9, 12, 15, 18, 21, and 24 months, for a total of 10 administrations.
Drug: DiaPep277
1.0 mg dose in 0.5 mL of solution
Placebo Comparator: Placebo
Administration of placebo, subcutaneously (s.c.) in the upper arm at 0, 1, 3, 6, 9, 12, 15, 18, 21, and 24 months, for a total of 10 administrations.
Drug: Placebo

40 mg mannitol in 0.5 mL of solution.

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


  Eligibility

Ages Eligible for Study:   20 Years to 45 Years   (Adult)
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 0.22 nmol/L, lower than 0.8 nmol/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
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: 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
Results First Received: November 16, 2015
Last Updated: April 19, 2016
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 August 24, 2016