Long-Term Treatment Effect of DiaPep277 in Type 1 Diabetes

Andromeda Biotech

Status and phase: Completed; Phase 3

Conditions: Type 1 Diabetes

Treatments: Drug: DiaPep277

Study type: Interventional

Funder types: Industry

Identifiers

NCT00644501

910

Details and patient eligibility

About

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.

Enrollment: 43 patients

Sex: All

Ages: 18 to 48 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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43 participants in 1 patient group

1

Experimental group

Treatment:

Drug: DiaPep277