Multiple Islet Peptide Administration in Type 1 Diabetes (MultiPepT1De)

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

27 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-10-20

Study Completion Date

2018-04-06

Brief Summary

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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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Detailed Description

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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.

Conditions

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Type 1 Diabetes

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Placebo injection

Water for injection

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type OTHER

Water for injection

MultiPepT1De injection low dose

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

Group Type EXPERIMENTAL

MultiPepT1De injection

Intervention Type DRUG

A mix of peptides

MultiPepT1De injection medium dose

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

Group Type EXPERIMENTAL

MultiPepT1De injection

Intervention Type DRUG

A mix of peptides

MultiPepT1De injection high dose

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

Group Type EXPERIMENTAL

MultiPepT1De injection

Intervention Type DRUG

A mix of peptides

Interventions

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MultiPepT1De injection

A mix of peptides

Intervention Type DRUG

Placebo

Water for injection

Intervention Type OTHER

Other Intervention Names

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Multipeptide injection

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Maximum Eligible Age

45 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No