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|
|Estimated Study Completion Date:||December 2011|
|Estimated 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.
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|