This study aimed to compare the effectiveness and safety of basal insulin (BI) and mid-mixture insulin (MMI) in a real-world setting. Chinese patients with T2DM uncontrolled on oral antihyperglycemic medications (OAMs) were randomized 1:1 to receive add-on BI (QD) or MMI (BID) for 48 weeks (wks). Insulin titration and OAM dose adjustment were based on clinical practice. Compared to BI, MMI led to numerically greater decrease in HbA1c from baseline to wk 24 and statistically greater decrease in HbA1c at wk 48. Fasting blood glucose (FBG) in both groups further decreased from wk 24 to wk 48, and BI caused greater decrease at wk 48 compared to MMI. Both groups had similar decreases in postprandial glucose. Also, significant intergroup difference in OAM use change was detected (p <0.0001) with more patients increasing OAM use in BI group and decreasing OAM use in MMI group. Noticeably, both groups had very limited insulin titration. Body weight increased subtly in both groups. Total hypoglycemia incidence was higher in MMI group through 48 wks, but both groups had low and similar nocturnal hypoglycemia incidence and no severe hypoglycemia. Both BI and MMI could significantly improve glycemic control in Chinese T2DM patients with OAM adjustment and limited insulin titration without major safety issues. Compared to BI, MMI showed larger improvement on glycemic control in relatively long period of treatment.
L. Chen: Consultant; Self; AstraZeneca, Eli Lilly and Company, Merck Sharp & Dohme Corp., Novo Nordisk A/S. H. Chen: Employee; Self; Eli Lilly and Company. L. Du: Employee; Self; Eli Lilly and Company. Y. Lou: Employee; Self; Eli Lilly and Company. L. Ji: None.
