Multiple Islet Peptide Administration in Type 1 Diabetes (MultiPepT1De)

Type 1 Diabetes Clinical Trial

— MultiPepT1De  

Official title:

Multiple Islet Peptide Administration in Type 1 Diabetes (MultiPepT1De)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02620332
• Other study ID #: MultiPep001
• Status: Completed
• Phase: Phase 1
• Start date: October 20, 2015
• Est. completion date: April 6, 2018

Study information

• Verified date: August 2019
• Source: King's College London
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 27
• Est. completion date: April 6, 2018
• Est. primary completion date: July 31, 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 45 Years

Eligibility

Inclusion Criteria:

• Clinical diagnosis of Type 1 diabetes

• Age 18-45 years

• Maximum of 4 years from diagnosis

• Evidence of =1 autoantibody against ß-cell autoantigens

• Possession of the HLA-DR4 (DRB1*0401) genotype

• Residual ß-cell function (peak C-peptide >200)

Exclusion Criteria:

• Females who are pregnant, breast-feeding or not using adequate forms of contraception.

• Use of ß-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

Related Conditions & MeSH terms

• Diabetes Mellitus
• Diabetes Mellitus, Type 1
• Type 1 Diabetes

Intervention

Drug:
• MultiPepT1De injection
A mix of peptides

Other:
• Placebo
Water for injection

Locations

Country	Name	City	State
United Kingdom	Guy's Hospital	London

Sponsors (2)

Lead Sponsor	Collaborator
King's College London	Guy's and St Thomas' NHS Foundation Trust

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Assessment of residual beta cell function and markers of metabolic control	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
Secondary	Assessment of T lymphocyte immune response to islet cell antigens	Comparison of changes in antigen specific T lymphocyte responses longitudinally following peptide treatment and versus placebo.	24 weeks versus 12 weeks