Title
Efficacy Study of DiaPep277 in Newly Diagnosed Type 1 Diabetes Patients
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
Phase
Phase 3Lead Sponsor
Andromeda Biotech Ltd.Study Type
InterventionalStatus
Completed Results PostedIndication/Condition
Type 1 DiabetesIntervention/Treatment
diapep277 ...Study Participants
457The 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.
1.0mg dose, administered as subcutaneous injection, on 0, 1, 3, 6, 9, 12, 15, 18 and 21 months
Mannitol (excipient) 40 mg, administered as subcutaneous injection on 1, 3, 6, 9, 12, 15, 18 and 21 months.
Inclusion Criteria: A diagnosis of type 1 diabetes for up to 3 months at screening Insulin dependency Fasting C-peptide levels >= 0.22 nmol/L Presence of at least 1 of the diabetes-related autoantibodies (IA-2A, GAD or IA) Exclusion Criteria: Pregnancy or intent to conceive in the next 2 years Significant diseases that could affect response to treatment, such as tumors, psychiatric disorders, substance abuse, severe allergies or diabetes-related complications. Patient has immune deficiency or receives immuno-suppressive or cytotoxic drugs.
| Event Type | Organ System | Event Term | DiaPep277 | Placebo |
|---|
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.
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.
