Home P D, Bolli G B, Mathieu C, Deerochanawong C, Landgraf W, Candelas C, Pilorget V, Dain M-P, Riddle M C
Institute for Cellular Medicine - Diabetes, Newcastle University, Newcastle upon Tyne, UK.
Diabetes Obes Metab. 2015 Jan;17(1):15-22. doi: 10.1111/dom.12329. Epub 2014 Jul 12.
To examine whether insulin glargine can lead to better control of glycated haemoglobin (HbA1c) than that achieved by neutral protamine Hagedorn (NPH) insulin, using a protocol designed to limit nocturnal hypoglycaemia.
The present study, the Least One Oral Antidiabetic Drug Treatment (LANCELOT) Study, was a 36-week, randomized, open-label, parallel-arm study conducted in Europe, Asia, the Middle East and South America. Participants were randomized (1:1) to begin glargine or NPH, on background of metformin with glimepiride. Weekly insulin titration aimed to achieve median prebreakfast and nocturnal plasma glucose levels ≤5.5 mmol/l, while limiting values ≤4.4 mmol/l.
The efficacy population (n = 701) had a mean age of 57 years, a mean body mass index of 29.8 kg/m², a mean duration of diabetes of 9.2 years and a mean HbA1c level of 8.2% (66 mmol/mol). At treatment end, HbA1c values and the proportion of participants with HbA1c <7.0 % (<53 mmol/mol) were not significantly different for glargine [7.1 % (54 mmol/mol) and 50.3%] versus NPH [7.2 % (55 mmol/mol) and 44.3%]. The rate of symptomatic nocturnal hypoglycaemia, confirmed by plasma glucose ≤3.9 or ≤3.1 mmol/l, was 29 and 48% less with glargine than with NPH insulin. Other outcomes were similar between the groups.
Insulin glargine was not superior to NPH insulin in improving glycaemic control. The insulin dosing algorithm was not sufficient to equalize nocturnal hypoglycaemia between the two insulins. This study confirms, in a globally heterogeneous population, the reduction achieved in nocturnal hypoglycaemia while attaining good glycaemic control with insulin glargine compared with NPH, even when titrating basal insulin to prevent nocturnal hypoglycaemia rather than treating according to normal fasting glucose levels.
采用旨在限制夜间低血糖的方案，研究甘精胰岛素在控制糖化血红蛋白（HbA1c）方面是否优于中性精蛋白锌胰岛素（NPH胰岛素）。
本研究即最少一种口服抗糖尿病药物治疗（LANCELOT）研究，是一项在欧洲、亚洲、中东和南美洲开展的为期36周的随机、开放标签、平行组研究。参与者被随机（1:1）分配，在二甲双胍联合格列美脲的基础上，开始使用甘精胰岛素或NPH胰岛素。每周进行胰岛素滴定，目标是使早餐前和夜间血浆葡萄糖水平中位数≤5.5 mmol/L，同时将≤4.4 mmol/L的情况限制在一定范围内。
疗效人群（n = 701）的平均年龄为57岁，平均体重指数为29.8 kg/m²，糖尿病平均病程为9.2年，平均HbA1c水平为8.2%（66 mmol/mol）。治疗结束时，甘精胰岛素组[7.1%（54 mmol/mol）和50.3%]与NPH胰岛素组[7.2%（55 mmol/mol）和44.3%]的HbA1c值以及HbA1c<7.0%（<53 mmol/mol）的参与者比例无显著差异。经血浆葡萄糖≤3.9或≤3.1 mmol/L确认的有症状夜间低血糖发生率，甘精胰岛素组比NPH胰岛素组分别低29%和48%。两组的其他结果相似。
甘精胰岛素在改善血糖控制方面并不优于NPH胰岛素。胰岛素给药算法不足以使两种胰岛素的夜间低血糖情况达到均衡。本研究证实，在全球异质性人群中，与NPH胰岛素相比，使用甘精胰岛素在实现良好血糖控制的同时，夜间低血糖有所减少，即使在滴定基础胰岛素以预防夜间低血糖而非根据正常空腹血糖水平进行治疗时也是如此。
