Efficacy Study of DiaPep277 in Newly Diagnosed Type 1 Diabetes Patients (DIA-AID)
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|ClinicalTrials.gov Identifier: NCT00615264|
Recruitment Status : Completed
First Posted : February 14, 2008
Results First Posted : June 6, 2016
Last Update Posted : June 6, 2016
|Condition or disease||Intervention/treatment||Phase|
|Type 1 Diabetes||Drug: DiaPep277 Drug: Placebo||Phase 3|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||457 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)|
|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 Patients|
|Study Start Date :||September 2005|
|Actual Primary Completion Date :||September 2011|
|Actual Study Completion Date :||January 2012|
DiaPep277 1.0 mg + 40 mg Mannitol in 0.5 mL lipid emulsion.
1.0mg dose, administered as subcutaneous injection, on 0, 1, 3, 6, 9, 12, 15, 18 and 21 months
Placebo Comparator: Placebo
Mannitol 40 mg in 0.5 mL lipid emulsion.
Mannitol (excipient) 40 mg, administered as subcutaneous injection on 1, 3, 6, 9, 12, 15, 18 and 21 months.
- Change From Baseline in Glucagon-stimulated C-peptide AUC at 24 Months [ Time Frame: Baseline and 24 months ]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 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.
- Change From Baseline in Mixed-meal Stimulated C-peptide AUC at 24 Months [ Time Frame: Baseline and 24 Months ]Beta cell function, measured as stimulated C-peptide secretion from 0 to 120 min post administration AUC, at baseline and 24 month measurements in a mixed-meal tolerance test (MMTT). The change in AUC was calculated per patient by subtracting the baseline AUC from the 24 month AUC.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00615264
|Principal Investigator:||Itamar Raz, MD||Hadassah Medical Center, Jerusalem|
|Principal Investigator:||Paolo Pozzilli, MD||Universita Campus Bio-Medico, Rome|
|Principal Investigator:||Francois Bonici, MD||New Groote Schuur Hospital, Cape Town|
|Principal Investigator:||Thomas Linn, MD||Universitätsklinikum, Giessen|