德谷胰岛素与甘精胰岛素对于2型糖尿病患者临床疗效及安全性的比较

Clinical efficacy and safety of insulin degludec and insulin glargine in patients with type 2 diabetes mellitus

目的比较德谷胰岛素和甘精胰岛素对于2型糖尿病患者的临床疗效及安全性的差异。方法选取就诊于石家庄市人民医院血糖控制不佳的2型糖尿病患者80例,随机分为2组(徳谷组和甘精组),每组40例,分别给予相应胰岛素治疗。前2周通过动态血糖仪监测,后续每周随访1次,共观察12周。检测指标包括空腹及餐后2 h血糖、HbA1c、胰岛素剂量以及反映血糖变异性的多个指标。结果共有75例患者完成随访,其中徳谷组39例,甘精组36例,2组人群年龄、BMI、血糖和HbA1c等基线资料差异无统计学意义。徳谷组的FPG-SD和FPG-CV低于甘精组(P<0.001),但2组间的TIR、MBG、SD、MAGE、LAGE和MODD等指标无明显差异。随访结束时,徳谷组的FPG和胰岛素剂量均低于甘精组(P<0.05),而2组的HbA1c和HbA1c下降幅度大致相同。无论是低血糖还是夜间低血糖,徳谷组的发生风险均低于甘精组(P<0.05)。结论德谷胰岛素具有不劣于甘精胰岛素的临床疗效,同时血糖变异性较小,低血糖风险更低,具有更高的安全性。

Objective To compare the clinical efficacy and safety of insulin degludec(IDeg)and insulin glargine(IGlar)in patients with type 2 diabetes mellitus(T2DM).Methods Totally 80 T2DM patients with poor plasma glucose control who were admitted to Shijiazhuang People’s Hospital were randomized 1:1 to receive either IDeg(IDeg group,n=40)or IGlar(IGlar group,n=40).Patients were monitored by dynamic blood glucose meter at the first two weeks,and the follow-up was performed after two weeks(once a week for 12 weeks).The fasting plasma glucose(FPG),2-h postprandial plasma glucose(2-hPG),Hemoglobin A1c(HbA1c),insulin dose and several indicators reflecting glycemic variability were compared.Results A total of 75 patients completed the follow-up,including 39 cases of IDeg and 36 cases of IGlar.There was no statistically significant difference in age,body mass index(BMI),plasma glucose,HbA1c between groups.The standard deviation of FPG(FPG-SD),FPG coefficient of variation(FPG-CV)in IDeg group were significantly lower than those of IGlar group(P<0.001).The time in range(TIR),mean blood glucose(MBG),standard deviation(SD),mean amplitude of glycemic excursion(MAGE),largest amplitude of glycemic excursion(LAGE)and mean of daily differences(MODD)were comparable between groups.At the end of follow-up,FPG and insulin dose in IDeg group were significantly lower than those in IGlar group(P<0.05),while HbA1c and the decrease amount of HbA1c in the two groups was roughly the same.The risk incidence of hypoglycemia and nocturnal hypoglycemia was significantly lower in IDeg group than that in IGlar group(P<0.05).Conclusion IDeg has the same clinical efficacy as IGlar,with less variability in plasma glucose,lower risk of hypoglycemia,and higher safety.