National and Kapodistrian University of Athens, Athens, Greece.
Aarhus University Hospital, Aarhus, Denmark.
Adv Ther. 2019 May;36(5):1201-1210. doi: 10.1007/s12325-019-00916-7. Epub 2019 Mar 16.
The stable, ultra-long duration of action of insulin degludec (degludec) minimizes fluctuations in glucose-lowering activity over the daily (24-h) dosing period, and comparative studies with other basal insulins suggest that these properties translate into a lower risk of hypoglycemia at equivalent levels of glycemic control. Results from the real-world European multicenter, retrospective chart review study of 2550 patients with type 1 and type 2 diabetes (T1D and T2D) in routine clinical care EU-TREAT (NCT02662114) showed that patients benefited from improved glycemic control and significantly reduced rates of hypoglycemia following a switch to degludec.
In this post hoc analysis, EU-TREAT patients were stratified into good (≤ 7.5% HbA1c), intermediate (> 7.5 to ≤ 8.5% HbA1c), and poor (> 8.5% HbA1c) glycemic control at baseline to investigate the possibility of differential benefits, either improved control or reduced risk of hypoglycemia, whichever the need. Changes in HbA1c, overall hypoglycemia, and total insulin dose from baseline to 6 and 12 months follow-up were assessed for each group.
For both T1D and T2D patients, those in good initial control experienced significant reductions in rates of hypoglycemia and total insulin dose following the switch, without compromising control. Those in poor initial control achieved significant improvements in HbA1c with no change in rates of hypoglycemia or total insulin dose.
This analysis expands the findings of EU-TREAT by showing differential changes in the clinical endpoints depending on particular need. It introduces the possibility that the differential benefits of degludec could address two of the renowned clinical challenges faced when treating diabetes: improving glycemic control for optimal management of T1D and titrating insulin dose in T2D, both without fear of increased hypoglycemia.
ClinicalTrials.gov, NCT02662114.
Novo Nordisk A/S.
胰岛素德谷胰岛素（德谷胰岛素）的作用稳定且持久，可将 24 小时治疗期间的降糖作用波动降至最低，与其他基础胰岛素的对比研究表明，这些特性可降低等效血糖控制水平下发生低血糖的风险。在常规临床护理中接受 2550 例 1 型和 2 型糖尿病（T1D 和 T2D）患者的真实欧洲多中心回顾性图表研究 EU-TREAT（NCT02662114）的结果表明，患者在改用德谷胰岛素后，血糖控制得到改善，且低血糖发生率显著降低。
在这项事后分析中，根据基线时的血糖控制情况（HbA1c≤7.5%、HbA1c>7.5 至≤8.5%、HbA1c>8.5%）将 EU-TREAT 患者分层，以探究不同治疗方案是否能带来更好的血糖控制或降低低血糖风险。评估每组患者从基线到 6 个月和 12 个月随访时的 HbA1c、总体低血糖和总胰岛素剂量的变化。
对于 T1D 和 T2D 患者，初始血糖控制良好的患者在转换后低血糖发生率和总胰岛素剂量显著降低，而血糖控制不受影响。初始血糖控制不佳的患者 HbA1c 显著改善，且低血糖发生率或总胰岛素剂量无变化。
这项分析通过显示不同的临床终点根据特定需求的变化，扩展了 EU-TREAT 的发现。它引入了一种可能性，即德谷胰岛素的差异化获益可能解决治疗糖尿病时面临的两个著名临床挑战：改善 T1D 的血糖控制以实现最佳管理，以及在 T2D 中调整胰岛素剂量，同时不用担心低血糖风险增加。
ClinicalTrials.gov，NCT02662114。
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