Insulin DEgludec/LIraglutide versus multiple daily insulin injections in the transition from hospital to outpatient management assessed by continuous glucose monitoring: the DELI transition trial.

AIMS/OBJECTIVE: The aim of the study was to assess the safety profile (defined as the percentage of patients with at least one hypoglycaemic event [more than 15 min with glucose levels <3.0 mmol/l as documented by continuous glucose monitoring] in the first 4 weeks of follow-up) for insulin degludec/liraglutide (IDegLira) compared with multiple daily insulin injections (MDI) during the transition from hospital to an outpatient setting. METHODS: The study was an open-label, randomised, controlled clinical trial comparing IDegLira to MDI after hospital discharge in patients with type 2 diabetes. The study evaluated the percentage of patients with at least one hypoglycaemic event, the hypoglycaemia event density, the time in range (TIR 3.8-10 mmol/l), the time below range (TBR <3.0 or <3.8 mmol/l), and other glycaemic management metrics measured by continuous glucose monitoring. RESULTS: Sixty-four patients were included in the analysis (32 in each group). They had a baseline HbA of 103  ±  11.6 mmol/mol (11.6 ± 1.7%) and age of 58 ± 12.4 years (means ± SD). The proportion of patients with at least one hypoglycaemic event (plasma glucose <3.0 mmol/l) was lower in the IDegLira group than in the MDI group (6.2% vs 31.3%; p<0.010), as was the hypoglycaemia event density (incidence rate ratio 15.2; 95% CI 6.2, 48.2; p<0.001), TBR <3.8 mmol/l (0.9% vs 2.9%; p=0.019) and TBR <3.0 mmol/l (0.6% vs 1.3%, p=0.008). The TIR 3.8-10 mmol/l was higher in the IDegLira group (80.6% vs 69.7%; p=0.008). The findings were consistent regardless of baseline HbA. CONCLUSIONS/INTERPRETATION: IDegLira proved to be safer and more effective than MDI for individuals with type 2 diabetes who had suboptimal glycaemic control, aiding in their transition from hospital to outpatient care. TRIAL REGISTRATION: Clinicaltrials.gov NCT05767255 FUNDING: This research was funded by a grant from the Asociación Colombiana de Endocrinología, Diabetes y Metabolismo (ACE).