Swinnen Sanne G, Simon Airin Cr, Holleman Frits, Hoekstra Joost B, Devries J Hans
Internal Medicine, Academic Medical Centre, Meibergdreef9, Amsterdam, Netherlands, 1105 AZ.
Cochrane Database Syst Rev. 2011 Jul 6;2011(7):CD006383. doi: 10.1002/14651858.CD006383.pub2.
Chronically elevated blood glucose levels are associated with significant morbidity and mortality. Many diabetes patients will eventually require insulin treatment to maintain good glycaemic control. There are still uncertainties about the optimal insulin treatment regimens for type 2 diabetes, but the long-acting insulin analogues seem beneficial. Several reviews have compared either insulin detemir or insulin glargine to NPH insulin, but research directly comparing both insulin analogues is limited.
To assess the effects of insulin detemir and insulin glargine compared with each other in the treatment of type 2 diabetes mellitus.
We searched MEDLINE, EMBASE, The Cochrane Library, online registries of ongoing trials and abstract books. Date of last search was January 2011.
All randomised controlled trials comparing insulin detemir with insulin glargine with a duration of 12 weeks or longer were included.
Two authors independently selected the studies and extracted the data. Pooling of studies by means of random-effects meta-analysis was performed.
This review examined four trials lasting 24 to 52 weeks involving 2250 people randomised to either insulin detemir or glargine. Overall, risk of bias of the evaluated studies was high. Insulin glargine was dosed once-daily in the evening. Insulin detemir was initiated once-daily in the evening with the option of an additional dose in the morning in three studies and initiated twice-daily in one study. Of randomised patients 13.6% to 57.2% were injecting insulin detemir twice-daily at the end of trial.Glycaemic control, measured by glycosylated haemoglobin A1c (HbA1c) and HbA1c equal to or less than 7% with or without hypoglycaemia, did not differ statistically significantly between treatment groups.The results showed no significant differences in overall, nocturnal and severe hypoglycaemia between treatment groups.Insulin detemir was associated with less weight gain. Treatment with insulin glargine resulted in a lower daily basal insulin dose and a lower number of injection site reactions.There was no significant difference in the variability of FPG or glucose values in 24-hour profiles between treatment groups. It was not possible to draw conclusions on quality of life, costs or mortality. Only one trial reported results on health-related quality of life and showed no significant differences between treatment groups.
AUTHORS' CONCLUSIONS: Our analyses suggest that there is no clinically relevant difference in efficacy or safety between insulin detemir and insulin glargine for targeting hyperglycaemia. However, to achieve the same glycaemic control insulin detemir was often injected twice-daily in a higher dose but with less weight gain, while insulin glargine was injected once-daily, with somewhat fewer injection site reactions.
长期血糖水平升高与显著的发病率和死亡率相关。许多糖尿病患者最终需要胰岛素治疗以维持良好的血糖控制。对于2型糖尿病的最佳胰岛素治疗方案仍存在不确定性，但长效胰岛素类似物似乎有益。几项综述比较了地特胰岛素或甘精胰岛素与中性鱼精蛋白锌胰岛素（NPH胰岛素），但直接比较这两种胰岛素类似物的研究有限。
评估地特胰岛素和甘精胰岛素在治疗2型糖尿病方面相互比较的效果。
我们检索了MEDLINE、EMBASE、Cochrane图书馆、正在进行的试验在线注册库和摘要书籍。最后一次检索日期为2011年1月。
纳入所有比较地特胰岛素和甘精胰岛素、持续时间为12周或更长时间的随机对照试验。
两位作者独立选择研究并提取数据。通过随机效应荟萃分析对研究进行合并。
本综述审查了四项持续24至52周的试验，涉及2250名随机分配至地特胰岛素或甘精胰岛素组的患者。总体而言，评估研究的偏倚风险较高。甘精胰岛素在晚上每日注射一次。地特胰岛素在三项研究中于晚上开始每日注射一次，可选择在早晨额外注射一次，在一项研究中开始每日注射两次。在试验结束时，随机分组的患者中有13.6%至57.2%每日注射地特胰岛素两次。通过糖化血红蛋白A1c（HbA1c）以及有无低血糖情况下HbA1c等于或低于7%来衡量的血糖控制，在治疗组之间无统计学显著差异。结果显示治疗组之间在总体、夜间和严重低血糖方面无显著差异。地特胰岛素与体重增加较少相关。甘精胰岛素治疗导致每日基础胰岛素剂量较低且注射部位反应数量较少。治疗组之间空腹血糖（FPG）或24小时血糖值曲线的变异性无显著差异。无法就生活质量、成本或死亡率得出结论。只有一项试验报告了与健康相关的生活质量结果，且显示治疗组之间无显著差异。
我们的分析表明，在针对高血糖方面，地特胰岛素和甘精胰岛素在疗效或安全性上无临床相关差异。然而，为实现相同的血糖控制，地特胰岛素通常每日注射两次，剂量较高但体重增加较少，而甘精胰岛素每日注射一次，注射部位反应略少。
