Long-Term Treatment Effect of DiaPep277 in Type 1 Diabetes

• Status: Completed
• Trial end date: 2013-06-01
• Target enrollment: 0
• Participant gender: All

Summary

The study is an open-label extension study, offering patients who participated and completed previous study 901 to continue treatment with DiaPep277 and clinical follow-up, for 2 additional years. The expectation is first to demonstrate that extended treatment with DiaPep277 is safe and second to evaluate the long-term effectiveness of treatment. Only patients who completed the previous 2-year study and still have beta-cell function above a threshold level will be eligible for this extension study.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Andromeda Biotech Ltd.

Criteria

Inclusion Criteria:

• A patient that participated in previous 461/PO and 901 studies and received all doses of study medication, per protocol.

• Evidence of clinically significant residual beta-cell function demonstrated by MMTT stimulated C-peptide concentrations ≥ 0.20 nmol/L.

Exclusion Criteria:

• The patient is pregnant or intends to become pregnant or is unwilling to use effective contraceptive method throughout the study.

• The subject has clinical evidence of any diabetes-related complication, or severe allergy or immune deficiency.