Type 1 Diabetes
Conditions
Brief summary
Type 1 diabetes is an autoimmune disease in which the insulin secreting βcells of the pancreas are destroyed such that the patient is reliant on injection of insulin to adequately control blood glucose levels for the remainder of his/her life. The autoimmune process targets proteins in beta-cells which are termed autoantigens. This is a Phase 1 study using a novel investigational medicinal product (IMP) known as MultiPepT1De in a study of safety and tolerability of administration in patients with recent onset Type 1 diabetes. MultiPepT1De is a mixture of peptides from islet auto antigens. The mixture has been designed to induce or restore immunological tolerance to the beta-cell and thus control or limit autoimmunity to protect beta-cells
Detailed description
Recent onset type 1 diabetes patients will be randomized into 4 groups of 6 subjects and each group will receive 6 injections of either placebo, low, medium or high dose of IMP; each injection is intradermal and spaced 1 month apart.
Interventions
DRUGMultiPepT1De injection
A mix of peptides
OTHERPlacebo
Water for injection
Sponsors
Guy's and St Thomas' NHS Foundation Trust
King's College London
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 45 Years
Healthy volunteers
No
Inclusion criteria
* Clinical diagnosis of Type 1 diabetes * Age 18-45 years * Maximum of 4 years from diagnosis * Evidence of ≥1 autoantibody against β-cell autoantigens * Possession of the HLA-DR4 (DRB1\*0401) genotype * Residual β-cell function (peak C-peptide \>200)
Exclusion criteria
* Females who are pregnant, breast-feeding or not using adequate forms of contraception. * Use of β-cell stimulants, immunosuppressive or immunomodulatory therapies, including systemic steroids within 1 month prior to randomization, any monoclonal antibody therapy given for any indication and any antigen-specific
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Assessment of MultiPepT1De safety profile | Every 28 days for 147 days | Safety assessed through measurement and comparison of any reactions or hypersensitivity to MultipepT1De injection vs placebo. Number of adverse events will also be compared between groups with the addition of safety monitoring blood tests |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Assessment of residual beta cell function and markers of metabolic control | 24 weeks versus baseline | Measured by a change in stimulated C-peptide production, daily insulin usage, glycated haemoglobin levels and amplitude of glucose excursions from baseline and between groups |
| Assessment of T lymphocyte immune response to islet cell antigens | 24 weeks versus 12 weeks | Comparison of changes in antigen specific T lymphocyte responses longitudinally following peptide treatment and versus placebo. |
Countries
United Kingdom
Outcome results
None listed