Title of research
Adaptive study of IL-2 dose on regulatory T cells in type 1 diabetes (DILT1D)
Institution
University of Cambridge and Cambridge University Hospitals Trust
Name of lead investigator
Dr Frank Waldron-Lynch
Research funded by
Wellcome Trust, JDRF & NIHR Cambridge Biomedical Research Centre
Who to contact
Dr Frank Waldron-Lynch
Tel: 01223 762327
Email: DILT1D@cimr.cam.ac.uk
Text: DILT1D to 82727
Web: www.clinical-trials-type1-diabetes.com
Recruiting until
January 2015
Total number of participants needed
40
Who can and cannot take part?
Participants should be aged 18-50 years and have been diagnosed with Type 1 diabetes within the last two years. People with a previous medical history of organ failure, organ transplant or severe heart disease are not eligible to take part.
What is the research about?
In people with Type 1 diabetes, the body’s immune system, which normally protects against infection and illness, turns around and attacks the cells of the pancreas that produce insulin. Ultimately these cells are destroyed or damaged to a point where they can no longer produce insulin. Researchers in this trial are using a drug called aldesleukin (interleukin-2) at low doses, to see if it can halt this destructive process and rebalance the immune system in people who have recently been diagnosed with Type 1 diabetes, and if so, to determine the appropriate dose needed to do so.
How will it benefit people with diabetes?
There is no guarantee that participants in this study will benefit from taking part. The study medication may halt the destruction of insulin-producing cells in the pancreas for a short while, but the overall purpose of the study is to see whether aldesleukin (interleukin-2) could be used to benefit people with Type 1 diabetes in future by helping to protect the pancreas from damage.
What will taking part involve for participants?
The study will involve a total of 12 appointments spread over approximately two months. Most of the visits will take place at Addenbrooke’s Hospital in Cambridge. During the first visit participants will provide consent and then will be screened to ensure that they are eligible to take part in the study. This will involve a series of tests including a physical exam, a chest x-ray, an ECG and blood and urine tests. The second visit will involve further tests and then participants will receive aldesleukin (interleukin-2) as an injection just beneath the skin.
To minimise the likelihood of side effects from the treatment, ultra low doses (approximately 50% less than that previously given to patients) will be used. Over the next nine weeks participants will be asked to attend 10 follow-up visits (five in the first week, two in the second week, and one each in weeks 3, 4 and 9). Each will involve further tests to monitor the participant’s health. During the study each participant will give a total of 400ml of blood (less than the amount taken when donating blood).
Further details are available at www.clinical-trials-type1-diabetes.com
What are the risks involved in taking part?
As with all medicines, there is a risk that participants may experience some unwanted side effects. The most common side effects reported as a result of low doses of aldesleukin are flu-like symptoms (fever, shivering, tiredness, runny nose, muscle pain and headaches), temporary soreness or redness at the point where the drug is injected and stomach upset with feelings of nausea, vomiting, abdominal pain or diarrhoea. If participants do experience these side effects, they are only likely to last a short time and will completely clear up afterwards.
Is there any compensation for taking part?
For visits to the hospital, participants will be fully reimbursed for the costs of travel, parking, meals, accommodation and child care that they might incur as a result of their participation in the study.