Topic: Diabetes Research Network
Conditions
Interventions
Drug: Aldesleukin (Proleukin)
A single, subcutaneous dose will be administered with the maximum dose allowed 1.5 X 106 IU/M2.
Sponsors
Cambridge University Hospitals NHS Foundation trust & University of Cambridge (UK)
Eligibility
Sex/Gender
All
Inclusion criteria
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
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| T regulatory cell response; Timepoint(s): The maximum value observed in each patient's profile over the first 7 days of the follow up period. | — |
Secondary
| Measure | Time frame |
|---|---|
| No secondary outcome measures | — |
Countries
United Kingdom
Outcome results
None listed