Efficacy and Safety Study of DiaPep277 in Newly Diagnosed Type 1 Diabetes Adults (DIA-AID2)
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.
|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|
- 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.
- 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 ]
- 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.
|Study Start Date:||April 2010|
|Study Completion Date:||October 2014|
|Primary Completion Date:||October 2014 (Final data collection date for primary outcome measure)|
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.
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.
40 mg mannitol in 0.5 mL of solution.
Dosing: 0, 1, 3, 6, 9, 12, 15, 18, 21, 24 months
Please refer to this study by its ClinicalTrials.gov identifier: NCT01103284
Show 75 Study Locations
|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|