Efficacy Study of DiaPep277 in Newly Diagnosed Type 1 Diabetes Patients (DIA-AID)
The purpose of this study is to determine if DiaPep277 can effectively protect the internal production of insulin in patients newly diagnosed with type 1 diabetes, by stopping the immune destruction of insulin-producing beta-cells in the pancreas. DiaPep277 acts on the immune system and is expected to prevent further destruction of the beta-cells by stimulating regulatory responses, without causing immunological suppression.
|Study Design:||Allocation: Randomized
Endpoint Classification: 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 Patients|
- Stimulated C-peptide, as determined by change from baseline in C-peptide AUC measured in a 20 minutes glucagon-stimulated test (GST) [ Time Frame: 0, to 24 months ] [ Designated as safety issue: No ]
- Percent of patients that achieve HbA1c=<7% [ Time Frame: 0, 3, 6, 9, 12, 15, 18, 21, 24 ] [ Designated as safety issue: No ]
- mixed-meal stimulated C-peptide secretion, as measured bychange in AUC from baseline to 24 months [ Time Frame: 0, 6, 12, 18, 24 ] [ Designated as safety issue: No ]
- Fasting C-peptide, as measured by change from baseline to 24 months. [ Time Frame: 24 months ] [ Designated as safety issue: No ]
|Study Start Date:||September 2005|
|Study Completion Date:||January 2012|
|Primary Completion Date:||September 2011 (Final data collection date for primary outcome measure)|
DiaPep277 1.0 mg + 40 mg Mannitol in 0.5ml lipid emulsion.
1.0mg dose, administered as subcutaneous injection, on 0, 1, 3, 6, 9, 12, 15, 18 and 21 months
Placebo Comparator: 2
Mannitol 40 mg in 0.5ml lipid emulsion.
Mannitol (excipient) 40 mg, administered as subcutaneous injection on 1, 3, 6, 9, 12, 15, 18 and 21 months.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00615264
Show 34 Study Locations
|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|