Multiple Islet Peptide Administration in Type 1 Diabetes (MultiPepT1De)

• Status: Completed
• Trial end date: 2018-04-06
• Target enrollment: 0
• Participant gender: All

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

• Phase: Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: King's College London
• Collaborator: Guy's and St Thomas' NHS Foundation Trust

Criteria

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