Regulatory T cells in Type 1 diabetes patients treated with IL-2

Recruitment & Eligibility

Status: Completed

Sex: All

Target Recruitment: 40

Inclusion Criteria

Current inclusion criteria as of 23/08/2013:
1. Type 1 diabetes
2. 18-50 years of age
3. Duration of diabetes less than 24 months from diagnosis
4. One positive auto-antibody (anti-islet cell, anti-GAD, anti-IA2, anti-ZnT8)

Previous inclusion criteria:
1. Type 1 diabetes
2. 18-50 years of age
3. Duration of diabetes more than 3 months but less than 24 months from diagnosis
4. One positive auto-antibody (anti-islet cell, anti-GAD, anti-IA2, anti-ZnT8)

Exclusion Criteria

Current exclusion criteria as of 23/08/2013:
1. Hypersensitivity to aldesleukin or any of the excipients
2. History of severe cardiac disease
3. 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
4. History or concurrent use of immunosuppressive agents or steroids.
5. History of unstable diabetes with recurrent hypoglycaemia
6. Active autoimmune, hyper or hypothyroidism
7. Active clinical infection
8. Major pre-existing organ dysfunction
9. Previous organ allograft
10. Females who are pregnant, lactating or intend to get pregnant during the study
11. Male who intend to father a pregnancy during the study
12. Donation of more than 500 ml of blood within 2 months prior to aldesleukin administration
13. Participation in a previous therapeutic clinical trial within 2 months prior to aldesleukin administration
14. Abnormal ECG
15. Abnormal full blood count, chronic renal failure, and/or impaired liver function
16. Positive HBsAg or HepC serology or HIV test
17. 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

Previous exclusion criteria:
1. Hypersensitivity to aldesleukin or any of the excipients
2. History of severe cardiac disease
3. 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
4. History or concurrent use of immunosuppressive agents or steroids.
5. History of unstable diabetes with recurrent hypoglycaemia
6. Hyper or hypothyroidism
7. Active clinical infection
8. Major pre-existing organ dysfunction
9. Previous organ allograft
10. Females who are pregnant, lactating or intend to get pregnant during the study
11. Male who intend to father a pregnancy during the study
12. Donation of more than 500 ml of blood within 2 months prior to aldesleukin administration
13. Participation in a previous therapeutic clinical trial within 2 months prior to aldesleukin administration
14. Abnormal ECG
15. Abnormal full blood count, chronic renal failure, and/or impaired liver function
16. Positive HBsAg or HepC serology or HIV test
17. 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