6/28/23, 10:58 PM LEUVEN-2 Pathway Feedback Search Clinical Topics Home Studies LEUVEN 2 LEUVEN 2 Disease In-hospital hyperglycemia Trial question Is intensive insulin therapy superior to conventional insulin therapy in medical ICU patients? Study design Multi-center Open label RCT Population Characteristics of study participants 38.6% female N = 1200 61.4% male 1200 patients (462 female, 738 male) Inclusion criteria: patients who have a need for intensive care for at least three days Key exclusion criteria: being in a surgical ICU; able to receive oral nutrition; under do-not- resuscitate orders Interventions N=595 intensive insulin therapy (blood glucose target 80-110 mg/dL) N=605 conventional insulin therapy (blood glucose target 180-200 mg/dL) Primary outcome Hospital death 40 40 0 % 37 3 https://web.pathway.md/studies/recIqW3HHEAwpfDpx 1/2 6/28/23, 10:58 PM 40.0 % LEUVEN-2 Pathway 0 37.3 30.0 % 20.0 % 10.0 % No significant difference 0.0 % Intensive insulin therapy Conventional insulin therapy No significant difference in hospital death (40% vs. 37.3%; AD 2.7%, 95% CI -2.68 to 8.08) Secondary outcomes Significant decrease in the rate of hospital death in patients who stayed in the ICU for 3 days (43% vs. 52.5%; ARD -9.5, 95% CI -16.63 to -2.37) Significant decrease in reduction in newly acquired kidney injury (5.9% vs. 8.9%; ARD -3, 95% CI -5.87 to -0.13) No significant difference in death from any cause at day 90 (35.9% vs. 37.7%; ARD -1.8, 95% CI -7.27 to 3.67) Conclusion In patients who have a need for intensive care for at least three days, intensive insulin therapy was not superior to conventional insulin therapy with respect to hospital death. Reference Greet Van den Berghe, Alexander Wilmer, Greet Hermans et al. Intensive insulin therapy in the medical ICU. N Engl J Med. 2006 Feb 2;354(5):449-61. Open reference URL https://web.pathway.md/studies/recIqW3HHEAwpfDpx 2/2