Division of Medical Sciences and Graduate Entry Medicine, School of Medicine, University of Nottingham, Nottingham, UK.
Diabet Med. 2017 Dec;34(12):1728-1736. doi: 10.1111/dme.13518. Epub 2017 Oct 14.
To evaluate the concordance between data derived from randomized controlled trial (RCT) and real-world estimates of HbA and weight change after 24 weeks of initiation of a basal-bolus compared with a premixed insulin regimen in people with Type 2 diabetes.
Data eight RCTs were pooled after a systematic review of studies examining basal-bolus (n = 1893) or premixed (n = 1517) regimens. Real-world data were extracted from the UK primary care dataset for people on basal-bolus (n = 7483) or premixed insulin regimens (n=10 744). The mean differences between HbA and weight from baseline were calculated using t-tests, while analysis of variance was used to compare the two treatment regimens. Linear regression analyses were used to determine the predictors of this change.
Both insulin regimens were associated with HbA reductions (real-world data -0.28%; RCT data, -1.4%) and weight gain (real-world data, +0.27 kg; RCT data, +2.96 kg) but there were no significant differences between basal-bolus and premixed insulin. Discordances in the pattern of treatment response were observed, however, between real-world and RCT data for both insulin regimens. For any given baseline HbA concentration, the change in HbA in the RCTs was greater than in real-world conditions and for those with baseline weight above ~60 kg, RCT data showed overall weight gain in contrast to slight weight loss in the real-world population. Lastly, for both randomized controlled trial and real-world populations, while greater baseline weight was associated with reduced response to treatment, the association was much steeper in the RCT than in the real-world population. In addition, greater baseline weight was associated with greater weight reductions in both premixed insulin and basal-bolus insulin regimens, although to a lesser extent with the latter.
These results highlight specific discrepancies in the HbA reduction and weight change in insulin regimen between real world versus RCT populations; with greater reduction in HbA and greater increase in weight observed in the RCT population than in the real-world population. Also, the basal-bolus regimens in both real-world and RCT populations showed greater reduction in HbA compared to the premix regimen (though more marked in RCTs), while the premix regimen showed greater increase in weight in real-world, as against basal-bolus in the RCT population.
评估在 24 周时，与预混胰岛素相比，接受基础-餐时胰岛素方案的 2 型糖尿病患者的糖化血红蛋白（HbA）和体重变化的随机对照试验（RCT）数据与真实世界数据的一致性。
系统评价了八项研究的 RCT 数据，这些研究比较了基础-餐时（n=1893）或预混（n=1517）方案。从英国初级保健数据集提取了基础-餐时（n=7483）或预混胰岛素方案（n=10744）的真实世界数据。使用 t 检验计算从基线开始的 HbA 和体重的平均差异，而方差分析用于比较两种治疗方案。线性回归分析用于确定这种变化的预测因素。
两种胰岛素方案均与 HbA 降低（真实世界数据-0.28%；RCT 数据-1.4%）和体重增加（真实世界数据+0.27kg；RCT 数据+2.96kg）相关，但基础-餐时和预混胰岛素之间无显著差异。然而，对于两种胰岛素方案，在真实世界和 RCT 数据之间观察到治疗反应模式存在差异。对于任何特定的基线 HbA 浓度，RCT 中的 HbA 变化大于真实世界条件，对于基线体重超过~60kg 的患者，RCT 数据显示总体体重增加，而真实世界人群则略有体重减轻。最后，对于 RCT 和真实世界人群，尽管基线体重较大与治疗反应降低相关，但这种关联在 RCT 中比在真实世界人群中更为陡峭。此外，基线体重较大与预混胰岛素和基础-餐时胰岛素方案的体重减轻都相关，尽管后者的关联较小。
这些结果突出了真实世界人群与 RCT 人群之间胰岛素方案的 HbA 降低和体重变化之间的特定差异；在 RCT 人群中观察到的 HbA 降低幅度更大，体重增加幅度更大。此外，与预混胰岛素方案相比，在真实世界和 RCT 人群中，基础-餐时方案显示出更大的 HbA 降低，尽管在 RCT 中更为明显，而预混胰岛素方案在真实世界人群中显示出更大的体重增加，而在 RCT 人群中则是基础-餐时方案。
