Multiple Islet Peptide Administration in Type 1 Diabetes (MultiPepT1De)

Phase 1

Completed

• Conditions: Type 1 Diabetes
• Interventions: Other: Placebo; Drug: MultiPepT1De injection

• Registration Number: NCT02620332
• Lead Sponsor: King's College London

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.

Study Timeline

• Study First Submitted: 2015-09-24
• Study Start: 2015-10-20
• Study First Submitted QC: 2015-12-01
• Study First Posted: 2015-12-03
• Primary Completion: 2017-07-31
• Study Completion: 2018-04-06
• Status Verified: 2019-08
• Last Update Submitted: 2019-08-12
• Last Update Posted: 2019-08-14

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 27

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Placebo injection	Placebo	Water for injection
MultiPepT1De injection low dose	MultiPepT1De injection	Mix of peptides administered once a month over a period of 20 weeks (6 injections in total)
MultiPepT1De injection medium dose	MultiPepT1De injection	Mix of peptides administered once a month over a period of 20 weeks (6 injections in total)
MultiPepT1De injection high dose	MultiPepT1De injection	Mix of peptides administered once a month over a period of 20 weeks (6 injections in total)

Primary Outcome Measures

Name	Time	Method
Assessment of MultiPepT1De safety profile	Every 28 days for 147 days	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

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Guy's Hospital; 🇬🇧 London, United Kingdom