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NCT Number: NCT02620332

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

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Key information

Conditions

Type 1 Diabetes Autoimmune Diseases Diabetes Mellitus Diabetes Mellitus, Type 1 Endocrine System Diseases Glucose Metabolism Disorders Immune System Diseases Metabolic Diseases Nutritional and Metabolic Diseases

Age range

18 year–45 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Guy's Hospital

London, SE1 9RT, United Kingdom

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

MultiPepT1De injection

Drug

A mix of peptides

Other names: Multipeptide injection

Placebo

Other

Water for injection

Primary outcomes

  1. Assessment of MultiPepT1De safety profile

    Time frame: 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 outcomes

  1. Assessment of residual beta cell function and markers of metabolic control

    Time frame: 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

  2. Assessment of T lymphocyte immune response to islet cell antigens

    Time frame: 24 weeks versus 12 weeks

    Comparison of changes in antigen specific T lymphocyte responses longitudinally following peptide treatment and versus placebo.

Sponsors and collaborators

Lead sponsor

King's College London

Other

Collaborators

  • Guy's and St Thomas' NHS Foundation Trust

Registry information

Acronym: MultiPepT1De

Important dates

Study start
2015
Primary completion
2017
Study completion
2018
First posted
Dec 3, 2015
Registry last updated
Aug 14, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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