DIABIL-2 will be a double-blind randomised placebo-controlled multicentre European trial assessing efficacy and safety of uld-IL2  in 200 recentlydiagnosed T1D patients. Our methodology strictly follows the Immunology of Diabetes Society consensus recommendations and European regulatory guidelines. The primary end-point is the change from baseline of AUC C-peptide during a mixed meal test at 1 year.

The workprogramme has been structured in 5 complementary workpackages (WP):

- WP1: will ensure effective and efficient coordination and management throughout the duration of the project.


- WP2: Clinical trials are governed by Regulatory and Good Practice rules (manufacturing of the product, clinical, laboratory). Compliance to these rules will be ensured during the first year as a mandatory prerequisite prior to undertaking our planned trial.


- WP3: We will carry out the DIABIL-2 trial from year 2 to year 3 in compliance with GCPs/GCLPs rules, and analyse the data during the fourth year of the project in order to verify the efficacy and safety of ultra-low-dose IL-2 in patients with recently diagnosed Type-1 Diabetes (T1D).


- WP4: we will gain insights into the molecular and cellular impact of ultra low-dose IL-2 treatment (versus a placebo control) in newly diagnosed T1D patients. Based on our previous studies and those of others, we expect a reduction in the autoimmune response associated with T1D in patients receiving IL-2 as compared to those receiving placebo. We also hypothesise that patients retaining more C-peptide will have a greater reduction in the assessed proinflammatory markers and antigen-specific responses.


- WP5: will organize a well targeted dissemination effort and early liaison with key stakeholders, including patients’ organisations and the pharmaceutical industry, in order to release the full exploitation potential of our approach.