Glycemic efficacy of insulin icodec and risk factors for hypoglycemia in patients with type 2 diabetes mellitus: a real-world study

Objective: To evaluate the real-world glycemic efficacy of Insulin Icodec in type 2 diabetes mellitus (T2DM) patients and identify independent risk factors for hypoglycemia. Methods: A retrospective cohort study enrolled 139 T2DM patients treated with Insulin Icodec (May 2024-December 2025). Glycemic efficacy was assessed by changes in HbA1c, fasting blood glucose (FBG), and target attainment rate (HbA1c <7.0%). Univariate analysis and Firth penalized logistic regression (correcting for rare-event bias) were used to identify hypoglycemia risk factors. Results: After 12-week treatment, median HbA1c decreased from 8.6% (IQR:7.5%-9.8%) to 6.9% (IQR:6.2%-7.8%) (Z=-10.246, P<0.001); target attainment rate was 58.3% (95%CI:49.7%- 66.5%). Hypoglycemia occurred in 4 cases (incidence:2.9%). All 4 events were non-severe (Level 1 or 2). Firth penalized logistic regression identified age ≥65 years (OR = 5.83, 95%CI:1.09-31.02, P = 0.040) and combined use of ≥2 oral antidiabetic drugs (OADs) (OR = 6.72, 95%CI:1.21-37.25, P = 0.029) as independent risk factors. No significant changes in liver/kidney function were observed (all P>0.05). Conclusion: Insulin Icodec exerts robust glycemic-lowering effects with good short-term safety in T2DM patients. Age ≥65 years and combined use of multiple OADs were identified as potential risk factors for hypoglycemia, although these findings are exploratory given the small number of events.