基础特征对100 U/mL甘精胰岛素低血糖风险的影响：BEYOND 7研究的事后分析
Effect of Baseline Characteristics on Hypoglycaemia Risk with Insulin Glargine 100 U/mL: Post Hoc Analysis of the BEYOND 7 Study.
作者信息
Wan Hailong, Wen Binhong, Wang Xueying, Wang Junfen, Zhang Yunliang, Ning Tao, Duan Binhong, Li Yufang, Feng Wei, Zhang Xia, Cui Nan, Ji Linong
机构信息
Panjin Central Hospital, Liaoning, China.
People's Hospital of Liaoning Province, Liaoning, China.
出版信息
Diabetes Ther. 2021 Sep;12(9):2359-2369. doi: 10.1007/s13300-021-01112-z. Epub 2021 Jul 21.
INTRODUCTION
BEYOND 7 demonstrated that a higher starting dose (0.3 U/kg) of insulin glargine 100 U/mL (Gla-100) is as safe as the standard starting dose (0.2 U/kg) in Chinese individuals with type 2 diabetes who had uncontrolled hyperglycaemia despite receiving oral antihyperglycaemic drugs. This post hoc analysis determined the effect of baseline characteristics on hypoglycaemia risk in these individuals.
METHODS
Participants from BEYOND 7 were assessed based on their age at baseline (< 60 vs. ≥ 60 years), duration of diabetes (< 10 vs. ≥ 10 years), glycated haemoglobin (HbA1c; < 9 vs. ≥ 9%) and fasting plasma glucose level (FPG; < 11 vs. ≥ 11 mmol/L). Endpoints included the proportion of participants with overall confirmed (≤ 3.9 mmol/L) and symptomatic hypoglycaemia, as well as the proportion of participants who achieved an HbA1c < 7% without hypoglycaemia, the time to first achievement of fasting blood glucose (FBG) < 7 mmol/L and the change in HbA1c from baseline between the two treatment arms in each of these subgroups.
RESULTS
The proportion of participants with overall confirmed (6.1-16.7%) or symptomatic hypoglycaemia (5.7-18.4%) or the proportion who achieved HbA1c < 7.0% without hypoglycaemia (23.6-47.4%) was similar between the two treatment arms in all subgroups, with the exception of participants with a baseline duration of diabetes ≥ 10 years who experienced more symptomatic hypoglycaemia if initiating Gla-100 at a dose of 0.3 versus 0.2 U/kg. Participants aged < 60 years with an HbA1c < 9% or ≥ 9% or a duration of diabetes of 2-10 years achieved an FBG < 7.0 mmol/L in a significantly shorter time with Gla-100 starting dose of 0.3 U/kg versus 0.2 U/kg (all p < 0.001). No significant differences were seen among the subgroups in terms of change from baseline in HbA1c.
CONCLUSIONS
Baseline age, duration of diabetes, HbA1c level and FPG level do not affect the risk of hypoglycaemia with a higher starting dose of Gla-100 versus its standard starting dose.
TRIAL REGISTRATION
ClinicalTrials.gov: NCT02836704.
简介
BEYOND 7研究表明，对于尽管接受口服降糖药治疗但血糖仍控制不佳的中国2型糖尿病患者，甘精胰岛素100 U/mL（Gla-100）起始剂量较高（0.3 U/kg）与标准起始剂量（0.2 U/kg）一样安全。这项事后分析确定了基线特征对这些患者低血糖风险的影响。
方法
根据BEYOND 7研究参与者的基线年龄（<60岁与≥60岁）、糖尿病病程（<10年与≥10年）、糖化血红蛋白（HbA1c；<9%与≥9%）和空腹血糖水平（FPG；<11与≥11 mmol/L）进行评估。终点包括总体确诊低血糖（≤3.9 mmol/L）和有症状低血糖的参与者比例，以及在无低血糖情况下HbA1c<7%的参与者比例、首次空腹血糖（FBG）<7 mmol/L的时间，以及每个亚组中两个治疗组之间HbA1c相对于基线的变化。
结果
在所有亚组中，两个治疗组总体确诊低血糖（6.1 - 16.7%）或有症状低血糖（5.7 - 18.4%）的参与者比例，或在无低血糖情况下达到HbA1c<7.0%的参与者比例（23.6 - 47.4%）相似，但糖尿病病程≥10年的参与者除外，这些参与者如果起始Gla-100剂量为0.3 U/kg比0.2 U/kg会经历更多有症状低血糖。基线HbA1c<9%或≥9%且年龄<60岁或糖尿病病程为2 - 10年的参与者，起始Gla-100剂量为0.3 U/kg比0.2 U/kg达到FBG<7.0 mmol/L的时间显著更短（所有p<0.001）。各亚组之间HbA1c相对于基线的变化无显著差异。
结论
基线年龄、糖尿病病程、HbA1c水平和FPG水平不影响较高起始剂量Gla-100相对于其标准起始剂量的低血糖风险。
试验注册
ClinicalTrials.gov：NCT02836704。
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