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

August 12, 2019 updated by: King's College London
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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

27

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 45 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / 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 Names:
  • 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 Names:
  • 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 Names:
  • Multipeptide injection

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
Every 28 days for 147 days

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
24 weeks versus baseline
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.
24 weeks versus 12 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

King's College London

Collaborators

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

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 20, 2015

Primary Completion (Actual)

July 31, 2017

Study Completion (Actual)

April 6, 2018

Study Registration Dates

First Submitted

September 24, 2015

First Submitted That Met QC Criteria

December 1, 2015

First Posted (Estimate)

December 3, 2015

Study Record Updates

Last Update Posted (Actual)

August 14, 2019

Last Update Submitted That Met QC Criteria

August 12, 2019

Last Verified

August 1, 2019

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • MultiPep001

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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