Multiple Islet Peptide Administration in Type 1 Diabetes (MultiPepT1De) | Recruiting
Multiple Islet Peptide Administrati... | Recruiting
Multiple Islet Peptide Administration in Type 1 Diabetes (MultiPepT1De)
MultiPepT1De

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Medical Conditions
  • Type 1 Diabetes
Primary Contact Details
Rhanya Chaabane
88472 00 44 071 88 7188
See all trial contact details
Recruitment Status
Recruiting
Trial source and source ID number
NCT02620332

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This information is designed to help you decide whether this trial is of interest. In some cases it is provided as a link to more detailed patient information or it may still be awaited from the organisation running the trial. Please look again shortly if the information you need is not here or, if named, contact the researcher named above.
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
Research Details
  • 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.
Phase
Phase 1
Study Design
Sorry, this information is not available
Study Type
Interventional
Intervention
Drug : MultiPepT1De injection, Other : Placebo

Study Arm Groups : MultiPepT1De injection low dose, MultiPepT1De injection medium dose, MultiPepT1De injection high dose, Placebo injection

Intervention Type
See Interventions above
Primary Outcome Measures
    Assessment of MultiPepT1De safety profile; Every 28 days for 147 days
Secondary Outcome Measures
    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
Publication(s)
Sorry, this information is not available
Result Reports
Check availability of results on the Clinicaltrials.gov website
This information is designed to help you decide whether this trial is of interest. In some cases it is provided as a link to more detailed patient information or it may still be awaited from the organisation running the trial. Please look again shortly if the information you need is not here or, if named, contact the researcher named above.
Gender
All
Age Range
18 Years - 45 Years
Who Can Participate
Patients
Number of Participants
24
Participant Inclusion Criteria
    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
Participant Exclusion Criteria
This is in the inclusion criteria above
This information is designed to help you decide whether this trial is of interest. In some cases it is provided as a link to more detailed patient information or it may still be awaited from the organisation running the trial. Please look again shortly if the information you need is not here or, if named, contact the researcher named above.
Trial Location(s)
Guy's Hospital
London
SE1 9RT
Trial Contact(s)
Primary Trial Contact
Rhanya Chaabane
88472 00 44 071 88 7188
Other Trial Contacts
Sorry, this information is not available
Countries Recruiting
United Kingdom
This information is designed to help you decide whether this trial is of interest. In some cases it is provided as a link to more detailed patient information or it may still be awaited from the organisation running the trial. Please look again shortly if the information you need is not here or, if named, contact the researcher named above.
Scientific Title
Multiple Islet Peptide Administration in Type 1 Diabetes (MultiPepT1De)
EudraCT Number
Not available for this trial
Funder(s)
  • Guy's and St Thomas' NHS Foundation Trust
Other Study ID Numbers
MultiPep001
Sponsor(s)
King's College London
Key Dates

Recruitment Start Date

Aug 2015

Recruitment End Date

Feb 2017

Trial Start Date
Date Not Available
Trial End Date
Date Not Available
Date added to source

24 Sep 2015

Date updated in source

01 Dec 2015