Multiple Islet Peptide Administration in Type 1 Diabetes (MultiPepT1De)

King's College London

Status and phase: Completed; Phase 1

Conditions: Type 1 Diabetes

Treatments: Other: Placebo; Drug: MultiPepT1De injection

Study type: Interventional

Funder types: Other

Identifiers

NCT02620332

MultiPep001

Details and patient eligibility

About

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

Full 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.

Enrollment: 27 patients

Sex: All

Ages: 18 to 45 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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27 participants in 4 patient groups, including a placebo group

Placebo injection

Placebo Comparator group

Description:

Water for injection

Treatment:

Other: Placebo

MultiPepT1De injection low dose

Experimental group

Description:

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

Treatment:

Drug: MultiPepT1De injection

MultiPepT1De injection medium dose

Experimental group

Description:

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

Treatment:

Drug: MultiPepT1De injection

MultiPepT1De injection high dose

Experimental group

Description:

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

Treatment:

Drug: MultiPepT1De injection