目的 比较德谷门冬双胰岛素、门冬胰岛素30在2型糖尿病(T2DM)非肥胖型患者中的血糖控制效果及安全性.方法 将T2DM非肥胖型患者依据治疗方式分为试验组和对照组.对照组给予门冬胰岛素30治疗,试验组给予德谷门冬双胰岛素治疗.比较2组治疗前后胰岛相关指标[空腹C肽(FCP)、餐后2 hC肽(2 h CP)]、血糖控制效果[空腹血糖(FBG)、餐后2 h血糖(2 h PG)、糖化血红蛋白(HbA1c)]、血清25羟基维生素D[25(OH)D]和低血糖发生风险.结果 试验组41例,对照组39例.治疗后,试验组和对照组的FCP分别为(0.84±0.09)和(1.07±0.14)nmol·L-1,2 h CP 分别为(1.03±0.15)和(1.69±0.17)nmol·L-1,FBG 分别为(5.46±0.57)和(6.18±0.67)mmol·L-1,2 h PG 分别为(8.17±0.85)和(9.03±0.94)mmol·L-1,HbA1c 分别为(5.35±0.57)%和(6.47±0.68)%,25(OH)D 分别为(26.33±2.75)和(20.54±2.17)nmol·L-1,在统计学上差异均有统计学意义(均P<0.05).治疗后,试验组和对照组的非严重低血糖发生率分别为14.63%和35.90%(P<0.05).试验组和对照组的严重低血糖发生率分别为9.76%和12.82%,夜间低血糖发生率分别为19.51%和17.95%,在统计学上差异均无统计学意义(均P>0.05).结论 德谷门冬胰岛素方案对T2DM非肥胖型的整体治疗效果优于门冬胰岛素30,前者可有效地调节患者血糖和胰岛细胞功能状态,降低发生非严重低血糖的风险.
Clinical trial of insulin degludec and insulin aspart and insulin aspart 30 in non-obese patients with type 2 diatetes meuitus
Objective To compare the blood glucose control effect and safety between insulin degludec and insulin aspart and insulin aspart 30 in non-obese patients with type 2 diabetes mellitus(T2DM).Methods Non-obese patients with T2DM were divided into treatment group and control group according to different treatment methods.The control group was treated with insulin aspart 30,and the treatment group was treated with insulin degludec and insulin aspart.Pancreatic islet related indicators[fasting C-peptide(FCP)and 2-hour postprandial C-peptide(2 h CP)],blood glucose control effect[fasting blood glucose(FBG),2-hour postprandial blood glucose(2 h PG)and glycated hemoglobin(HbA1c)],serum 25-hydroxyvitamin D[25(OH)D]and the risk of hypoglycemia were compared between the two groups.Results There were 41 cases in treatment group and 39 cases in control group.After treatment,FCP levels in treatment group and control group were(0.84±0.09)and(1.07±0.14)nmol·L-1;2 h CP levels were(1.03±0.15)and(1.69±0.17)nmol·L-1;FBG levels were(5.46±0.57)and(6.18±0.67)mmol·L-1;2 h PG levels were(8.17±0.85)and(9.03±0.94)mmol·L-1;HbA1 c were(5.35±0.57)%and(6.47±0.68)%;25(OH)D levels were(26.33±2.75)and(20.54±2.17)nmol·L-1,all with significant difference(all P<0.05).The incidence rates of non-severe hypoglycemia in treatment group and control group were 14.63%and 35.90%,with statistically significant difference(P<0.05).The incidence rates of severe hypoglycemia in treatment group and control group were 9.76%and 12.82%;the incidence rates of nocturnal hypoglycemia were 19.51%and 17.95%,without statistically significant difference(all P>0.05).Conclusion The overall therapeutic effect of insulin degludec and insulin aspart on non-obese patients with T2DM is better than that of insulin aspart 30.The former can effectively regulate blood glucose and pancreatic islet cell function,lower the risk of non-severe hypoglycemia.
insulin degludec and insulin aspartinsulin aspart 30type 2 diabetes mellitusblood glucose controlfasting C-peptide25-hydroxyvitamin D