Open-Label Extension Study to Evaluate Long Term Safety and Treatment Effect of DiaPep277® (DIA-AID 2)
|Study Design:||Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||Open-Label Study to Evaluate Long Term Safety and Treatment Effect of DiaPep277® in Subjects Who Have Completed Study 1001 (NCT01103284)|
- Hypoglycemic Events [ Time Frame: At Early Termination Visit, Up to 25 Months ] [ Designated as safety issue: Yes ]The number of hypoglycemic events recorded by each patient over the course of the study.
- Change From Baseline in Glucagon-stimulated C-peptide AUC at Early Termination Visit [ Time Frame: Baseline and Early Termination Visit, Up to 25 Months ] [ Designated as safety issue: No ]Beta-cell function, measured as change in stimulated C-peptide secretion measured 0, 2, 6, 10 and 20 minutes post administration [area under the curve (AUC), 0-20 minutes] at Baseline and the early termination visit (up to 25 months), during a glucagon stimulation test (GST). Change was calculated for each patient by subtracting the baseline AUC value (defined as the last non-missing assessment prior to first dose in the 1010 study but after the end of study 1001) from the early termination visit AUC.
- Change From Baseline in Daily Insulin Dose, Per kg Body Weight, at Early Termination Visit [ Time Frame: Baseline and Early Termination Visit, up to 25 months ] [ Designated as safety issue: No ]
- Glycemic Control (Change From Baseline in % HbA1c) [ Time Frame: Baseline and Early Termination Visit, Up to 25 Months ] [ Designated as safety issue: No ]
|Study Start Date:||October 2013|
|Study Completion Date:||December 2014|
|Primary Completion Date:||September 2014 (Final data collection date for primary outcome measure)|
Administration of DiaPep277® to patients previously enrolled in the Phase 3 Study 1001 (NCT01103284)
1 mg of DiaPep277® subcutaneously in the upper arm at 0, 3, 6, 9, 12, 15, 18, and 21 months, for a total of 8 administrations
Treatment with DiaPep277® is expected to be long-term; stopping treatment may result in the eventual loss of the preserved beta-cell function. Indeed, extension of phase 2 studies has shown that patients who were initially treated with DiaPep277® and maintained their initial beta-cell function, required continuation of treatment, losing beta-cell function if switched to Placebo. These extension studies were too small for the outcome to be statistically significant, but they suggested that continuation of treatment is needed for long-term maintenance of efficacy.
Therefore, in this extension study, patients who complete the 1001 phase 3 study (NCT01103284) and maintain clinically significant beta-cell function are offered a 2-year continuation of active treatment, since they are likely to benefit from use of the medication. The participation in the extension study will be offered to all eligible subjects who complete the 1001 study, regardless of the treatment arm allocation in the initial study.
By achieving long-term preservation of beta-cell function, patients are expected to maintain good management of the disease, manifesting as better glycemic control and fewer hypoglycemic events.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01898286
|United States, Georgia|
|Atlanta Diabetes associates|
|Atlanta, Georgia, United States, 30318|
|United States, Michigan|
|Henry Ford Medical Centers - New Center One|
|Detroit, Michigan, United States, 48202|
|United States, North Carolina|
|Mountain Diabetes and Endocrine Center|
|Asheville, North Carolina, United States, 28803|
|Principal Investigator:||Itamar Raz, MD||Hadassah Medical Center, Jerusalem|