DILT1DAdaptive Study of IL-2 Dose on Regulatory T Cells in Type 1 Diabetes (DILT1D)
Aldesleukin (Proleukin)
Autoimmune Diseases+5
+ Diabetes Mellitus
+ Endocrine System Diseases
Basic Science Study
Summary
Study start date: March 1, 2013
Actual date on which the first participant was enrolled.Type 1 diabetes is the most common severe chronic autoimmune disease worldwide and is caused by the autoimmune (loss of self tolerance) mediated destruction of the insulin producing pancreatic beta cells thus leading to insulin deficiency and development of hyperglycaemia. Currently, medical management of type 1 diabetes focuses on intensive insulin replacement therapy to limit complications (retinopathy, nephropathy, neuropathy); nevertheless clinical outcomes remain sub optimal. There are intensive efforts to design novel immunotherapies that can arrest the autoimmune process and thereby preserve residual insulin production leading to fewer complications and better clinical outcomes. The vast majority of genes that contribute to susceptibility to type 1 diabetes have been found to encode proteins involved in immune regulation and function. In particular, several susceptibility proteins are involved in the interleukin 2 (IL-2) pathway that regulates T cell activation and tolerance to self antigens. Aldesleukin is a human recombinant IL-2 product produced by recombinant DNA technology using genetically engineered E. coli stain containing an analog of the human interleukin-2 gene. There is substantial nonclinical, preclinical and clinical data that ultra low dose IL-2 (aldesleukin) therapy can arrest the autoimmune mediated destruction of pancreatic beta cells by induction of functional T regulatory cells. However, prior to embarking on large proof of concept trials in type 1 diabetes it is essential that the optimum dose of IL-2 (aldesleukin) is determined. The objective of this study is to establish in patients with type 1 diabetes the optimal dose of IL-2 (aldesleukin) to administer in order to increase T regulatory cell response.
Protocol
This section provides details of the study plan, including how the study is designed and what the study is measuring.40 patients to be enrolled
Total number of participants that the clinical trial aims to recruit.Basic Science Study
Eligibility
Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.Any sex
Biological sex of participants that are eligible to enroll.From 18 to 50 Years
Range of ages for which participants are eligible to join.Healthy volunteers not allowed
If individuals who are healthy and do not have the condition being studied can participate.Conditions
Pathology
Criteria
Inclusion Criteria: Written informed consent Type 1 diabetes 18-50 years Duration of diabetes less than 24 months from diagnosis One positive autoantibody (anti-islet cell, anti-GAD, anti-IA2, anti-ZnT8) Exclusion Criteria: Hypersensitivity to aldesleukin or any of the excipients History of severe cardiac disease History of malignancy within the past 5 years (with the exception of localized carcinoma of the skin that had been resected for cure or cervical carcinoma in situ) History or concurrent use of immunosuppressive agents or steroids History of unstable diabetes with recurrent hypoglycaemia Active autoimmune, hyper or hypothyroidism Active clinical infection Major pre-existing organ dysfunction or previous organ allograft Females who are pregnant, lactating or intend to get pregnant during the study - Males who intend to father a pregnancy during the study Donation of more than 500 ml of blood within 2 months prior to aldesleukin administration Participation in a previous therapeutic clinical trial within 2 months prior to aldesleukin administration Abnormal ECG Abnormal full blood count, chronic renal failure (Stage 3,4,5) and/or evidence impaired liver function Positive Hepatitis B surface Antigen (HBsAg) or Hepatitis C serology or Human Immunodeficiency Virus (HIV) test Any medical history or clinically relevant abnormality that is deemed by the principal investigator and/or medical monitor to make the patient ineligible for inclusion because of a safety concern
Study Plan
Find out more about all the medication administered in this study, their detailed description and what they involve.Study Objectives
Primary Objectives
Secondary Objectives
Study Centers
These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.This study has 1 location
Wellcome Trust Clinical Research Facility, Addenbrooke's Hospital
Cambridge, United KingdomOpen Wellcome Trust Clinical Research Facility, Addenbrooke's Hospital in Google Maps