Valley Research, Fresno, California.
Concord Repatriation General Hospital, Sydney, Australia.
Diabetes Obes Metab. 2017 Nov;19(11):1562-1569. doi: 10.1111/dom.12972. Epub 2017 Jul 10.
To re-analyse, using a series of alternative hypoglycaemia definitions, the data from 2 trials, DUAL I and V, in which the once-daily, fixed ratio combination of insulin degludec/liraglutide (IDegLira) was compared with basal insulin therapy.
Post hoc analyses of the DUAL I (patients uncontrolled on oral antidiabetic drugs) and DUAL V (patients uncontrolled on insulin glargine (IGlar) U100) trials were carried out using different definitions of hypoglycaemia and according to whether treatments were administered in the morning or afternoon. Rates of hypoglycaemia for the definitions of confirmed and American Diabetes Association (ADA)-documented symptomatic hypoglycaemia were compared according to age, gender and body mass index (BMI).
Although hypoglycaemia rates differed according to the alternative hypoglycaemia definitions, rates were consistently lower with IDegLira vs insulin degludec (IDeg) and IGlar U100. Despite glycated haemoglobin concentrations being lower with IDegLira at end of treatment, confirmed and nocturnal-confirmed hypoglycaemia rates were lower for IDegLira vs IDeg and IGlar U100, irrespective of dosing time. The definitions of confirmed and ADA-documented symptomatic hypoglycaemia did not have a significant effect on the treatment difference between IDegLira and IDeg, liraglutide or IGlar U100 when further assessed by baseline age, gender and BMI.
Treatment with IDegLira, vs IDeg and IGlar U100, resulted in lower rates of hypoglycaemia regardless of dosing time and definition of hypoglycaemia used. The choice of hypoglycaemia definition did not influence the results of analyses when stratified by age, sex and BMI.
使用一系列替代的低血糖定义重新分析两项试验（DUAL I 和 V）的数据，这两项试验比较了每日一次、固定比例的胰岛素德谷胰岛素/利拉鲁肽（IDegLira）与基础胰岛素治疗。
对 DUAL I（口服抗糖尿病药物控制不佳的患者）和 DUAL V（胰岛素甘精 U100 控制不佳的患者）试验进行了事后分析，使用不同的低血糖定义，并根据治疗是在早上还是下午进行。根据年龄、性别和体重指数（BMI）比较了不同定义的确诊和美国糖尿病协会（ADA）记录的有症状低血糖的低血糖发生率。
尽管低血糖发生率因替代低血糖定义而异，但与胰岛素德谷胰岛素（IDeg）和胰岛素甘精 U100 相比，IDegLira 的低血糖发生率始终较低。尽管治疗结束时 IDegLira 的糖化血红蛋白浓度较低，但无论给药时间如何，IDegLira 与 IDeg 和胰岛素甘精 U100 的确诊和夜间确诊低血糖发生率均较低。在进一步按基线年龄、性别和 BMI 评估时，确诊和 ADA 记录的有症状低血糖的定义对 IDegLira 与 IDeg、利拉鲁肽或胰岛素甘精 U100 之间的治疗差异没有显著影响。
无论给药时间和使用的低血糖定义如何，与 IDeg 和胰岛素甘精 U100 相比，使用 IDegLira 治疗可降低低血糖发生率。当按年龄、性别和 BMI 分层时，低血糖定义的选择并不影响分析结果。
