Logo 1 Logo 2

Clinical Trial Details

Trial ID: L4308
Source ID: NCT01827735
Associated Drug: Aldesleukin (Proleukin)
Title: Regulatory T Cells in Type 1 Diabetes Patients Treated With IL-2
Acronym: DILT1D
Status: COMPLETED
Study Results: NO
Results:
Conditions: Type 1 Diabetes
Interventions: DRUG: Aldesleukin (Proleukin)
Outcome Measures: Primary: The primary endpoint is based upon the percentage of CD4+T regulatory (defined as CD3+CD4+CD25highCD127low) cells within the CD3+CD4+T cell gate following treatment with IL-2., Fluorescence-activated cell sorting assay, From Day 0 to Day 60 | Secondary: T regulatory cell phenotype and stability, Fluorescence-activated cell sorting assay, From Day 0 to Day 60|T effector cell number and phenotype, Fluorescence-activated cell sorting assay, From Day 0 - Day 60|T cell subset proliferation and populations, Fluorescence-activated cell sorting assay, From Day 0 - Day 60|Intracellular T cell and natural killer(NK) cell signalling, Fluorescence-activated cell sorting assay, From Day 0 - Day 60|T regulatory cell function, T suppression assay, From Day 0 - Day 60|IL-2 pathway genotype, DNA sequencing, From Day 0 - Day 60|Lymphocyte Subsets, Complete blood count, From Day 0 to Day 60|Serum Cytokines, Enzyme-linked immuno sorbent assay, From Day 0 to Day 60|Glycaemic control, Self monitoring blood glucose readings, HbA1c, insulin usage, From Day 0 to Day 60|Number of Participants with Adverse Events as a Measure of Safety and Tolerability, From Day O to Day 60
Sponsor/Collaborators: Sponsor: Cambridge University Hospitals NHS Foundation Trust | Collaborators: University of Cambridge|Juvenile Diabetes Research Foundation|National Institute for Health Research, United Kingdom|Wellcome Trust
Gender: ALL
Age: ADULT
Phases: PHASE1|PHASE2
Enrollment: 40
Study Type: INTERVENTIONAL
Study Designs: Allocation: NA|Intervention Model: SINGLE_GROUP|Masking: NONE|Primary Purpose: BASIC_SCIENCE
Start Date: 2013-03
Completion Date: 2014-05
Results First Posted:
Last Update Posted: 2015-06-23
Locations: Wellcome Trust Clinical Research Facility, Addenbrooke's Hospital, Cambridge, CB2 0QQ, United Kingdom
URL: https://clinicaltrials.gov/show/NCT01827735