2型糖尿病患者在使用不同胰岛素治疗方案联合二甲双胍治疗时糖化血红蛋白（HbA1c）与低血糖之间的关系

Relationship between HbA1c and hypoglycaemia in patients with type 2 diabetes treated with different insulin regimens in combination with metformin.

作者信息

Chan John Y C, Leyk Malgorzata, Frier Brian M, Tan Meng H

机构信息

Eli Lilly Canada Inc., Toronto, Ontario, Canada.

出版信息

Diabetes Metab Res Rev. 2009 Mar;25(3):224-31. doi: 10.1002/dmrr.929.

DOI:10.1002/dmrr.929

PMID:19156705

Abstract

BACKGROUND

To examine the relationship between glycaemic control and hypoglycaemia in patients with type 2 diabetes treated with metformin (Met) and either insulin lispro mixtures, given twice or thrice daily (LM + Met), or insulin glargine, given once daily (G + Met).

METHODS

Data from three randomized clinical trials were pooled to compare effects of LM + Met with G + Met.

RESULTS

The LM + Met group achieved lower mean HbA(1c) (mean+/-SE, 7.2+/-0.1 vs. 7.7+/-0.1%, p<0.0001) and all meals combined post-prandial blood glucose (BG) (8.9+/-0.1 vs. 10.2+/-0.1 mmol/L, p<0.0001) compared with the G + Met group, but had higher fasting blood glucose (8.1+/-0.1 vs. 6.8+/-0.1 mmol/L, p<0.0001) and insulin requirement (0.7+/-0.01 vs. 0.6+/-0.01 U/kg, p<0.0001). Over the entire study period, daytime hypoglycaemia was higher for the LM + Met group (10.3 vs. 3.5 episodes/patient/year, p<0.0001) than for the G + Met group; however, nocturnal hypoglycaemia was lower (3.4 vs. 6.6 episodes/patient/year, p=0.003). At endpoint, daytime hypoglycaemia was higher for the LM + Met group (6.2 vs. 1.4 episodes/patient/year, p<0.0001); however, nocturnal hypoglycaemia was similar in both groups (1.9 vs. 3.0 episodes/patient/year). An inverse relationship was observed between all confirmed hypoglycaemia and HbA(1c) at endpoint; for every 1% reduction in HbA(1c), the increase (in slope) was 1.4 episodes/patient/year (p=0.04). Patients with confirmed hypoglycaemia had lower HbA(1c) than patients without hypoglycaemia (7.39 vs. 7.64%, respectively; decrement=0.26%, p=0.026).

CONCLUSIONS

These studies demonstrated an inverse relationship between HbA(1c) and 24-h and daytime hypoglycaemia. Lispro insulin mixtures provided lower HbA(1c) and post-prandial blood glucose values than glargine, but caused more daytime hypoglycaemia. Frequency of nocturnal hypoglycaemia was similar and severe hypoglycaemia was rare with both insulin regimens.

摘要

背景

探讨接受二甲双胍（Met）治疗的2型糖尿病患者，联合一日两次或三次注射赖脯胰岛素混合制剂（LM + Met）或一日一次注射甘精胰岛素（G + Met）时，血糖控制与低血糖之间的关系。

方法

汇总三项随机临床试验的数据，比较LM + Met与G + Met的效果。

结果

与G + Met组相比，LM + Met组的平均糖化血红蛋白（HbA1c）水平更低（均值±标准误，7.2±0.1 vs. 7.7±0.1%，p<0.0001），三餐合并后的餐后血糖（BG）也更低（8.9±0.1 vs. 10.2±0.1 mmol/L，p<0.0001），但空腹血糖更高（8.1±0.1 vs. 6.8±0.1 mmol/L，p<0.0001），胰岛素需求量也更大（0.7±0.01 vs. 0.6±0.01 U/kg，p<0.0001）。在整个研究期间，LM + Met组的日间低血糖发生率高于G + Met组（10.3 vs. 3.5次/患者/年，p<0.0001）；然而，夜间低血糖发生率更低（3.4 vs. 6.6次/患者/年，p = 0.003）。在研究终点，LM + Met组的日间低血糖发生率更高（6.2 vs. 1.4次/患者/年，p<0.0001）；然而，两组的夜间低血糖发生率相似（1.9 vs. 3.0次/患者/年）。在研究终点，所有确诊的低血糖事件与HbA1c之间呈负相关；HbA1c每降低1%，（斜率）增加1.4次/患者/年（p = 0.04）。确诊低血糖的患者HbA1c低于未发生低血糖的患者（分别为7.39%和7.64%；差值 = 0.26%，p = 0.026）。