Multiple Islet Peptide Administration in Type 1 Diabetes (MultiPepT1De)
NCT02620332 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 27
Last updated 2019-08-14
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
Conditions
Interventions
- DRUG
-
MultiPepT1De injection
A mix of peptides
- OTHER
-
Placebo
Water for injection
Sponsors & Collaborators
-
Guy's and St Thomas' NHS Foundation Trust
collaborator OTHER - lead OTHER
Principal Investigators
-
Jake Powrie, MD FRCP · Guy's and St Thomas' NHS Foundation Trust
-
Mark Peakman, MBBS PhD · King's College London
Study Design
- Allocation
- RANDOMIZED
- Purpose
- TREATMENT
- Masking
- QUADRUPLE
- Model
- PARALLEL
Eligibility
- Min Age
- 18 Years
- Max Age
- 45 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2015-10-20
- Primary Completion
- 2017-07-31
- Completion
- 2018-04-06
Countries
- United Kingdom
Study Locations
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