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Multiple Islet Peptide Administration in Type 1 Diabetes (MultiPepT1De) (MultiPepT1De)

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ClinicalTrials.gov Identifier: NCT02620332
Recruitment Status : Completed
First Posted : December 3, 2015
Last Update Posted : August 14, 2019
Sponsor:
Collaborator:
Guy's and St Thomas' NHS Foundation Trust
Information provided by (Responsible Party):
King's College London

Study Description
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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

Condition or disease Intervention/treatment Phase
Type 1 Diabetes Drug: MultiPepT1De injection Other: Placebo Phase 1

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 Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 27 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Multiple Islet Peptide Administration in Type 1 Diabetes (MultiPepT1De)
Actual Study Start Date : October 20, 2015
Actual Primary Completion Date : July 31, 2017
Actual Study Completion Date : April 6, 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Diabetes Type 1

Arms and Interventions
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Arm Intervention/treatment
Placebo Comparator: Placebo injection
Water for injection
 Other: Placebo
Water for injection
Experimental: MultiPepT1De injection low dose
Mix of peptides administered once a month over a period of 20 weeks (6 injections in total)
 Drug: MultiPepT1De injection
A mix of peptides
Other Name: Multipeptide injection
Experimental: MultiPepT1De injection medium dose
Mix of peptides administered once a month over a period of 20 weeks (6 injections in total)
 Drug: MultiPepT1De injection
A mix of peptides
Other Name: Multipeptide injection
Experimental: MultiPepT1De injection high dose
Mix of peptides administered once a month over a period of 20 weeks (6 injections in total)
 Drug: MultiPepT1De injection
A mix of peptides
Other Name: Multipeptide injection


Outcome Measures
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Primary Outcome Measures :
  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 Outcome Measures :
  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.


Eligibility Criteria
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Ages Eligible for Study:   18 Years to 45 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02620332


Locations
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United Kingdom
Guy's Hospital
London, United Kingdom, SE1 9RT
Sponsors and Collaborators
King's College London
Guy's and St Thomas' NHS Foundation Trust
Investigators
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Principal Investigator: Jake Powrie, MD FRCP Guy's and St Thomas' NHS Foundation Trust
Study Director: Mark Peakman, MBBS PhD King's College London
More Information
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Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: King's College London
ClinicalTrials.gov Identifier: NCT02620332    
Other Study ID Numbers: MultiPep001
First Posted: December 3, 2015    Key Record Dates
Last Update Posted: August 14, 2019
Last Verified: August 2019
Additional relevant MeSH terms:
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Diabetes Mellitus
Diabetes Mellitus, Type 1
Glucose Metabolism Disorders
Metabolic Diseases
 Endocrine System Diseases
Autoimmune Diseases
Immune System Diseases