Objective To compare the efficacy and safety between generic and original insulin glargine in treatment of type 2 diabetes.Methods Retrospective cohort study was used to collect the information of type 2 diabetes patients who used insulin glargine and were hospitalized twice or more from January 1st,2022 to September 30th,2023.The propensity score matching(PSM)was used to balance the baseline levels of covariates between the generic and original insulin glargine groups.The efficacy and safety of two groups were compared after at least three months.The primary outcome was the change of HbAlc from the baseline,and the secondary outcome was the change of fasting blood glucose(FBG)from baseline and the standard-reaching rate of HbAlc＜7.0％.Safety was assessed based on adverse events that included hypoglycemia,and rash.Results Before PSM,there were significant differences between the two groups in age,duration of diabetes,combination use of other antidiabetic agents(P＜0.05).After PSM,there were not statistically significant between two groups at baseline.The differences between the original group and the generic group in the reduction of HbAlc,the reduction of FBG and the standard-reaching rate of HbAlc 7.0％were not statistically significant.There was also no statistically significant difference in the incidence of hypoglycemia and rash between the two groups.Conclusion The efficacy and safety of generic insulin glargine in the treatment of type 2 diabetes are not inferior to the original drug.
关键词
甘精胰岛素注射液/生物仿制药/原研药/有效性/安全性/倾向匹配法
Key words
generic and original insulin glargine/biosimilars/original drug/efficacy/safety/propensity score matching
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