Multiple Islet Peptide Administration in Type 1 Diabetes (MultiPepT1De)

Phase 1CompletedNCT02620332

King's College London27 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

QUADRUPLE

Enrollment

Conditions

Type 1 Diabetes

Interventions

Eligibility

Sex: ALLMin age: 18 YearsMax age: 45 Years

Medical Language ↔ Plain English

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

Outcomes

Primary Outcomes

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

Time frame: Every 28 days for 147 days

Secondary Outcomes

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

Time frame: 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.

Time frame: 24 weeks versus 12 weeks