| Trial ID: | L4083 |
| Source ID: | NCT01898286
|
| Associated Drug: |
Diapep277®
|
| Title: |
Open-Label Extension Study to Evaluate Long Term Safety and Treatment Effect of DiaPep277®
|
| Acronym: |
DIA-AID 2
|
| Status: |
TERMINATED
|
| Study Results: |
YES
|
| Results: |
https://ClinicalTrials.gov/show/NCT01898286/results
|
| Conditions: |
Type 1 Diabetes
|
| Interventions: |
DRUG: DiaPep277®
|
| Outcome Measures: |
Primary: Hypoglycemic Events, The number of hypoglycemic events recorded by each patient over the course of the study., At Early Termination Visit, Up to 25 Months | Secondary: Change From Baseline in Glucagon-stimulated C-peptide AUC at Early Termination Visit, 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., Baseline and Early Termination Visit, Up to 25 Months | Other: Change From Baseline in Daily Insulin Dose, Per kg Body Weight, at Early Termination Visit, Baseline and Early Termination Visit, up to 25 months|Glycemic Control (Change From Baseline in % HbA1c), Baseline and Early Termination Visit, Up to 25 Months
|
| Sponsor/Collaborators: |
Sponsor: Andromeda Biotech Ltd.
|
| Gender: |
ALL
|
| Age: |
ADULT
|
| Phases: |
PHASE3
|
| Enrollment: |
38
|
| Study Type: |
INTERVENTIONAL
|
| Study Designs: |
Allocation: NA|Intervention Model: SINGLE_GROUP|Masking: NONE|Primary Purpose: TREATMENT
|
| Start Date: |
2013-10
|
| Completion Date: |
2014-12
|
| Results First Posted: |
2016-05-26
|
| Last Update Posted: |
2016-05-26
|
| Locations: |
Atlanta Diabetes associates, Atlanta, Georgia, 30318, United States|Henry Ford Medical Centers - New Center One, Detroit, Michigan, 48202, United States|Mountain Diabetes and Endocrine Center, Asheville, North Carolina, 28803, United States
|
| URL: |
https://clinicaltrials.gov/show/NCT01898286
|
