Clinical trial NCT02620332: Multiple Islet Peptide Administration in Type 1 Diabetes (MultiPepT1De)
Official title: Multiple Islet Peptide Administration in Type 1 Diabetes (MultiPepT1De)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Type 1 Diabetes
Lead sponsor: King's College London
Sponsor class: OTHER
Collaborators: name: Guy's and St Thomas' NHS Foundation Trust
First posted: 2015-12-03
Enrollment: 27
Sex: ALL
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility 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

Primary outcomes:
measure: Assessment of MultiPepT1De safety profile
timeFrame: Every 28 days for 147 days
Secondary outcomes:
measure: Assessment of residual beta cell function and markers of metabolic control
timeFrame: 24 weeks versus baseline
measure: Assessment of T lymphocyte immune response to islet cell antigens
timeFrame: 24 weeks versus 12 weeks
Other outcomes:
Locations:
city: London
country: United Kingdom
facility: Guy's Hospital
Study officials:
affiliation: Guy's and St Thomas' NHS Foundation Trust
name: Jake Powrie, MD FRCP
role: PRINCIPAL_INVESTIGATOR
affiliation: King's College London
name: Mark Peakman, MBBS PhD
role: STUDY_DIRECTOR
References:
citation: Liu YF, Powrie J, Arif S, Yang JHM, Williams E, Khatri L, Joshi M, Lhuillier L, Fountoulakis N, Smith E, Beam C, Lorenc A, Peakman M, Tree T. Immune and Metabolic Effects of Antigen-Specific Immunotherapy Using Multiple beta-Cell Peptides in Type 1 Diabetes. Diabetes. 2022 Apr 1;71(4):722-732. doi: 10.2337/db21-0728.