Now Available: Final Rule for FDAAA 801 and NIH Policy on Clinical Trial Reporting

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

April 13, 2010
April 19, 2016
April 2010
October 2014   (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 ]
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.
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 ]
Complete list of historical versions of study NCT01103284 on ClinicalTrials.gov Archive Site
  • 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 ]
Percent of subjects that achieve good glycemic control: HbA1c<7% [ Time Frame: 25 months ] [ Designated as safety issue: Yes ]
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.
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 Efficacy 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 in 0.5 mL of solution
  • Drug: Placebo

    40 mg mannitol in 0.5 mL of solution.

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

  • 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.
    Intervention: Drug: DiaPep277
  • 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.
    Intervention: Drug: Placebo

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
475
October 2014
October 2014   (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 0.22 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
Both
20 Years to 45 Years   (Adult)
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
Not Provided
Not Provided
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.
April 2016

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