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

This study is currently recruiting participants. (see Contacts and Locations)
Verified December 2015 by King's College London
Sponsor:
Collaborator:
Guy's and St Thomas' NHS Foundation Trust
Information provided by (Responsible Party):
King's College London
ClinicalTrials.gov Identifier:
NCT02620332
First received: September 24, 2015
Last updated: December 1, 2015
Last verified: December 2015
  Purpose
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 Intervention Phase
Type 1 Diabetes
Drug: MultiPepT1De injection
Other: Placebo
Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Multiple Islet Peptide Administration in Type 1 Diabetes (MultiPepT1De)

Resource links provided by NLM:


Further study details as provided by King's College London:

Primary Outcome Measures:
  • 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:
  • 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

  • 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.


Estimated Enrollment: 24
Study Start Date: August 2015
Estimated Study Completion Date: February 2017
Estimated Primary Completion Date: February 2017 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02620332

Contacts
Contact: Rhanya Chaabane 00 44 071 88 7188 ext 88472 multipeptide@gstt.nhs.uk

Locations
United Kingdom
Guy's Hospital Recruiting
London, United Kingdom, SE1 9RT
Contact: Rhanya Chaabane    00 44 7188 7188 ext 88472    multipeptide@gstt.nhs.uk   
Sponsors and Collaborators
King's College London
Guy's and St Thomas' NHS Foundation Trust
Investigators
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

Additional Information:
Responsible Party: King's College London
ClinicalTrials.gov Identifier: NCT02620332     History of Changes
Other Study ID Numbers: MultiPep001 
Study First Received: September 24, 2015
Last Updated: December 1, 2015

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 1
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Autoimmune Diseases
Immune System Diseases

ClinicalTrials.gov processed this record on February 24, 2017