Long-Term Treatment Effect of DiaPep277 in Type 1 Diabetes

Andromeda Biotech Ltd.43 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Type 1 Diabetes

Interventions

DiaPep277DRUG

1.0mg dose, injected subcutaneously at baseline and every 3 months thereafter (at 0, 3, 6, 9, 12, 15, 18, 21 months)for a total of 8 administrations.

Eligibility

Sex: ALLMin age: 18 YearsMax age: 48 Years

Medical Language ↔ Plain English

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.

Locations (3)

Wolfson Medical Centre

Holon, Israel

Diabetic Unit, Hadassah Medical Center

Jerusalem, Israel

Schneider Children's Medical Centre

Petah Tikva, Israel

Outcomes

Primary Outcomes

Preservation of endogenous insulin secretion/beta-cell function, as measured by mixed-meal tolerance test stimulated C-peptide secretion.

Time frame: every 6 months up to 24 months from T0

Secondary Outcomes

improved metabolic control and the insulin dose required to maintain it.

Time frame: every 3 months up to 24 months from T0

Data from ClinicalTrials.gov

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