德谷胰岛素和甘精胰岛素在中国北方1型糖尿病患者中血糖控制方面的差异性研究

Variability of insulin degludec and insulin glargine in northern Chinese patients with type 1 diabetes

目的比较德谷胰岛素(IDeg)与甘精胰岛素(IGlar)在中国北方1型糖尿病患者中血糖变异性(GV)的差异。方法采用开放标签、随机、双向交叉研究,16例接受餐时加基础胰岛素治疗的中国北方1型糖尿病患者随机(1∶1)分到2个治疗序列(A:基础胰岛素为IDeg-IGlar,B:基础胰岛素为IGlar-IDeg),在为期2周的每个治疗期间评估分别使用2种胰岛素患者的血糖变化情况,并根据空腹C肽水平及混合餐耐受实验刺激后C肽水平将合格的受试者分为C肽<0.2 nmol/L组与C肽≥0.2 nmol/L组,比较在不同C肽水平的患者中2种胰岛素对血糖变异性的影响。所有患者均使用扫描式动态血糖监测(FGM)系统评估血糖变化。结果IDeg的24 h血糖水平的标准差(SD)、血糖波动的平均幅度(MAGE)、日间血糖平均绝对差(MODD)均低于IGlar,差异无统计学意义(P>0.05)。葡萄糖在目标范围内(3.9~10 mmol/L)的时间百分比(TIR)在2种胰岛素间的差异无统计学意义(P=0.990)。C肽<0.2 nmol/L组患者使用2种胰岛素类似物时,MAGE的差异有统计学意义[(IDeg(5.5±2.1)mmol/L vs.IGlar(8.3±2.8)mmol/L,P=0.037)]。IDeg的空腹血糖SD及变异系数(CV)显著低于IGlar[(1.5±1.1)mmol/L vs.(2.4±1.3)mmol/L;18.0%±9.3%vs.25.8%±10.2%,P<0.05]。低血糖参数在2种胰岛素间差异无统计学意义(P>0.05)。结论德谷胰岛素治疗可能提供非常显著的临床益处,特别是在C肽无应答的患者中。

Objective To compare the difference in GV between IDeg and IGlar in patients with type 1 diabetes in northern China.Methods In this open-label,randomized,2-way crossover study,16 northern Chinese diabetic patients on basal-bolus therapy were randomly assigned to two therapeutic sequences in a 1∶1 ratio(A:IDeg-IGlar,B:IGlar-IDeg).FGM device was used during each 2-week treatment period to evaluate their GV with two types of insulin.Subjects were divided into the C-peptide<0.2 nmol/L group and the C-peptide≥0.2 nmol/L group according to the fasting C-peptide concentrations and peak C-peptide concentrations during a mixed-meal tolerance test.The blood glucose variability in patients with different levels of C-peptide indexes after IDeg and IGlar were compared.Results Major indicators of GV-the SD of the 24h blood glucose level,MAGE,and MODD of IDeg were lower than those of insulin glargine,but there was no statistical significance(P>0.05).There was no significant difference in TIR within the target range(3.9~10 mmol/L)(P=0.990).There was a statistically significant difference in MAGE in the C-peptide<0.2 nmol/L group when treated with the two insulin analgesic agents IDeg(5.5±2.1)mmol/L vs.IGlar(8.3±2.8)mmol/L,(P=0.037).The SD and coefficient of variation(CV)of fasting plasma glucose with IDeg were significantly lower than those with IGlar(1.5±1.1)mmol/L vs.(2.4±1.3)mmol/L;18.0%±9.3%vs.25.8%±10.2%,(P<0.05).There was no significant difference in hypoglycemia parameters between the two types of insulin(P>0.05).Conclusion The treatment with IDeg may offer very significant clinical benefits,especially in the group of patients with no response to C-peptide.