Once-daily basal insulin glargine versus thrice-daily prandial insulin lispro in people with type 2 diabetes on oral hypoglycaemic agents (APOLLO): an open randomised controlled trial
Once-daily basal insulin glargine versus thrice-daily prandial insulin lispro in people with type 2 diabetes on oral hypoglycaemic agents (APOLLO): an open randomised controlled trial
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DOI：
10.1016/s0140-6736(08)60485-7
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发表时间：
2008-03-01
期刊：
影响因子：
168.9
通讯作者：
Linn, Thomas
中科院分区：
文献类型：
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作者：
Bretzel, Reinhard G.;Nuber, Ulrike;Linn, Thomas
背景：随着2型糖尿病的进展，口服降糖药往往不能维持血糖控制，需要胰岛素。我们研究了口服降糖药的2型糖尿病患者，在总体血糖控制中，每天服用一次甘精胰岛素是否不低于每天三次的每日一餐甘精胰岛素。方法在欧洲和澳大利亚的69个研究地点进行了为期44周的平行开放研究，将418名口服降糖药物控制不佳的2型糖尿病患者随机分为甘精胰岛素每日一次，每天同一时间服用一次，或每天三次口服赖斯普罗。主要目的是比较两种方案从基线到终点(第44周)的血红蛋白A(1c)的变化。随机化是通过中央随机化服务完成的。分析按方案进行。这项研究在ClinicalTrials.gov上注册，编号为NCT00311818。结果205名患者被随机分配到甘精胰岛素组，210名患者被分配到利斯普罗胰岛素组。甘精胰岛素组的平均血红蛋白A(1c)降低为-1。7%(从8.7%[SD 1.0]至7.0%[0.71])和-1。9%(从8.7%到6.8%[0.90])，这在非劣势的预先设定的0.4%范围内(差异=0.157；95%CI-0.008到0.322)。甘精胰岛素组106例(57%)患者的血红蛋白A(1c)低于7%，而赖斯普罗组有131例(69%)。甘精素组平均空腹血糖下降(-4.3[SD2.3]mmol/L vs-1。8[2.3]mmo1/L；p
Background As type 2 diabetes mellitus progresses, oral hypoglycaemic agents often fail to maintain blood glucose control and insulin is needed. We investigated whether the addition of once-daily insulin glargine is non-inferior to three-times daily prandial insulin lispro in overall glycaemic control in adults with inadequately controlled type 2 diabetes mellitus taking oral hypoglycaemic agents.Methods In the 44-week, parallel, open study that was undertaken in 69 study sites across Europe and Australia, 418 patients with type 2 diabetes mellitus that was inadequately controlled by oral hypoglycaemic agents were randomly assigned to either insulin glargine taken once daily at the same time every day or to insulin lispro administered three times per day. The primary objective was to compare the change in haemoglobin A(1c) from baseline to endpoint (week 44) between the two regimens. Randomisation was done with a central randomisation service. Analysis was per protocol. This study is registered with ClinicalTrials.gov, number NCT00311818.Findings 205 patients were randomly assigned to insulin glargine and 210 to insulin lispro. Mean haemoglobin A(1c) decrease in the insulin glargine group was -1 . 7% (from 8.7% [SD 1 . 0] to 7.0% [0.71]) and -1 . 9% in the insulin lispro group (from 8.7% [1.0] to 6.8% [0.9]), which was within the predefined limit of 0.4% for non-inferiority (difference=0.157; 95% Cl -0.008 to 0.322).106 (57%) patients reached haemoglobin A(1c) of 7% or less in the glargine group and 131 (69%) in the lispro group. In the glargine group, the fall in mean fasting blood glucose (-4.3 [SD 2.3] mmol/L vs -1 . 8 [2.3] mmol/L; p