OBJECTIVES: To investigate health related quality of life (HRQL) using EuroQol EQ-5D in patients with type 2 diabetes over the 24 months following insulin initiation. METHODS: INSTIGATE is a European prospective observational study investigating patients with type 2 diabetes initiating insulin during usual care. Follow-up data on resource use, treatment, clinical and patient reported outcomes over the 24 months following insulin initation were collected in Germany, Greece and Spain (N=564). RESULTS: Mean (SD) HbA1c was 9.4(1.72)% at insulin initiation, 7.2(1.03)% after 6 months, and 7.2(1.07)% after 24 months. Only in Germany did mean HbA1c fall below 7%. Treatment approach varied; at baseline in Germany patients were prescribed more intensive insulin regimens (mean 3.1 injections/day). In Greece and Spain most patients were prescribed either basal-only or premix-only with fewer mean daily injections (1.8 and 1.4 respectively). Across all patients at baseline, 14.5% reported problems with the EQ-5D self-care dimension, 37.9% reported problems with mobility and 31.4% with usual activities. In Greece, 68% of patients reported problems with anxiety/depression (overall: 54.1%); in Germany, 63% reported problems with pain/discomfort (overall: 52.3%). In the five dimensions, 62.4-80.3% of patients reported no change between baseline and 24 months, 10.4-16.1% reported worsening problems, and 8.6-22.9% reported improvement. Mean(SD) baseline EQ-5D visual analogue scale scores (VAS) were: Germany 65.7(19.07), Greece 64.8(19.24), Spain 63(18.32). Patients in Greece saw the greatest and most sustained improvement in VAS; mean increase from baseline to 6 months 13.9(15.08) and baseline to 24 months 11.9(17.82). In Germany and Spain increases from baseline to 6 months were 12.4(16.5) and 4.6(17.69) respectively. From baseline to 24 months there was an increase of only 6.1(18.86) in Germany and 6.7(20.83) in Spain. CONCLUSIONS: Following insulin initiation there was an increase in HRQL (VAS) through 6 months, although this appeared to diminish between 6 and 24 months.