Type 1 Diabetes
Conditions
Keywords
type 1 diabetes, beta cells, immunomodulation, immunointervention
Brief 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.
Interventions
DRUGDiaPep277
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.
Sponsors
Andromeda Biotech Ltd.
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 48 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Preservation of endogenous insulin secretion/beta-cell function, as measured by mixed-meal tolerance test stimulated C-peptide secretion. | every 6 months up to 24 months from T0 |
Secondary
| Measure | Time frame |
|---|---|
| improved metabolic control and the insulin dose required to maintain it. | every 3 months up to 24 months from T0 |
Countries
Israel
Outcome results
None listed