Multiple Islet Peptide Administration in Type 1 Diabetes (MultiPepT1De)

Study Overview
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Brief Summary
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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
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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.

Official Title
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Multiple Islet Peptide Administration in Type 1 Diabetes (MultiPepT1De)

Conditions
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Type 1 Diabetes

Intervention / Treatment
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* Drug: MultiPepT1De injection
* Other: Placebo


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 45 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: Placebo injection<br>Water for injection | Other: Placebo<br>* Water for injection<br>|
| Experimental: MultiPepT1De injection low dose<br>Mix of peptides administered once a month over a period of 20 weeks (6 injections in total) | Drug: MultiPepT1De injection<br>* A mix of peptides<br>* Other names: Multipeptide injection;|
| Experimental: MultiPepT1De injection medium dose<br>Mix of peptides administered once a month over a period of 20 weeks (6 injections in total) | Drug: MultiPepT1De injection<br>* A mix of peptides<br>* Other names: Multipeptide injection;|
| Experimental: MultiPepT1De injection high dose<br>Mix of peptides administered once a month over a period of 20 weeks (6 injections in total) | Drug: MultiPepT1De injection<br>* A mix of peptides<br>* Other names: Multipeptide injection;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Assessment of MultiPepT1De safety profile | 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 | Every 28 days for 147 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Assessment of residual beta cell function and markers of metabolic control | 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 | 24 weeks versus baseline | 
| Assessment of T lymphocyte immune response to islet cell antigens | Comparison of changes in antigen specific T lymphocyte responses longitudinally following peptide treatment and versus placebo. | 24 weeks versus 12 weeks |