Multiple Islet Peptide Administration in Type 1 Diabetes (MultiPepT1De)

Multiple Islet Peptide Administration in Type 1 Diabetes (MultiPepT1De)

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

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.

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