NCT02620332

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
27

participants targeted

Target at P25-P50 for phase_1

Timeline
Completed

Started Oct 2015

Typical duration for phase_1

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

September 24, 2015

Completed
26 days until next milestone

Study Start

First participant enrolled

October 20, 2015

Completed
1 month until next milestone

First Posted

Study publicly available on registry

December 3, 2015

Completed
1.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 31, 2017

Completed
8 months until next milestone

Study Completion

Last participant's last visit for all outcomes

April 6, 2018

Completed
Last Updated

August 14, 2019

Status Verified

August 1, 2019

Enrollment Period

1.8 years

First QC Date

September 24, 2015

Last Update Submit

August 12, 2019

Conditions

Type 1 Diabetes

Outcome Measures

Primary Outcomes (1)

  • Assessment of MultiPepT1De safety profile

    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 Outcomes (2)

  • Assessment of residual beta cell function and markers of metabolic control

    24 weeks versus baseline

  • Assessment of T lymphocyte immune response to islet cell antigens

    24 weeks versus 12 weeks

Study Arms (4)

Placebo injection

PLACEBO COMPARATOR

Water for injection

Other: Placebo

MultiPepT1De injection low dose

EXPERIMENTAL

Mix of peptides administered once a month over a period of 20 weeks (6 injections in total)

Drug: MultiPepT1De injection

MultiPepT1De injection medium dose

EXPERIMENTAL

Mix of peptides administered once a month over a period of 20 weeks (6 injections in total)

Drug: MultiPepT1De injection

MultiPepT1De injection high dose

EXPERIMENTAL

Mix of peptides administered once a month over a period of 20 weeks (6 injections in total)

Drug: MultiPepT1De injection

Interventions

MultiPepT1De injectionDRUG

A mix of peptides

Also known as: Multipeptide injection
MultiPepT1De injection high doseMultiPepT1De injection low doseMultiPepT1De injection medium dose
PlaceboOTHER

Water for injection

Placebo injection

Eligibility Criteria

Age18 Years - 45 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • 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)

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Guy's Hospital

London, SE1 9RT, United Kingdom

Location

Related Publications (1)

  • Liu YF, Powrie J, Arif S, Yang JHM, Williams E, Khatri L, Joshi M, Lhuillier L, Fountoulakis N, Smith E, Beam C, Lorenc A, Peakman M, Tree T. Immune and Metabolic Effects of Antigen-Specific Immunotherapy Using Multiple beta-Cell Peptides in Type 1 Diabetes. Diabetes. 2022 Apr 1;71(4):722-732. doi: 10.2337/db21-0728.

    PMID: 35073398DERIVED

MeSH Terms

Conditions

Diabetes Mellitus, Type 1

Condition Hierarchy (Ancestors)

Diabetes MellitusGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System DiseasesAutoimmune DiseasesImmune System Diseases

Study Officials

  • Jake Powrie, MD FRCP

    Guy's and St Thomas' NHS Foundation Trust

    PRINCIPAL INVESTIGATOR

  • Mark Peakman, MBBS PhD

    King's College London

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 24, 2015

First Posted

December 3, 2015

Study Start

October 20, 2015

Primary Completion

July 31, 2017

Study Completion

April 6, 2018

Last Updated

August 14, 2019

Record last verified: 2019-08

Locations

GB(1)