Rodbard H W, Buse J B, Woo V, Vilsbøll T, Langbakke I H, Kvist K, Gough S C L
Endocrine and Metabolic Consultants, Rockville, MD, USA.
Diabetes Care Center, School of Medicine, University of North Carolina, Chapel Hill, NC, USA.
Diabetes Obes Metab. 2016 Jan;18(1):40-8. doi: 10.1111/dom.12574. Epub 2015 Nov 5.
To evaluate, using post hoc analyses, whether the novel combination of a basal insulin, insulin degludec, and a glucagon-like peptide-1 receptor agonist, liraglutide (IDegLira), was consistently effective in patients with type 2 diabetes (T2D), regardless of the stage of T2D progression.
Using data from the DUAL I extension [insulin-naïve patients uncontrolled on oral antidiabetic drugs (OADs), n = 1660, 52 weeks] and DUAL II (patients uncontrolled on basal insulin plus OADs, n = 398, 26 weeks) randomized trials, the efficacy of IDegLira was investigated with regard to measures of disease progression stage including baseline glycated haemoglobin (HbA1c), disease duration and previous insulin dose.
Across four categories of baseline HbA1c (≤7.5-9.0%), HbA1c reductions were significantly greater with IDegLira (1.1-2.5%) compared with IDeg or liraglutide alone in DUAL I. In DUAL II, HbA1c reductions were significantly greater with IDegLira (0.9-2.5%) than with IDeg in all but the lowest HbA1c category. In DUAL I, insulin dose and hypoglycaemia rate were lower across all baseline HbA1c categories for IDegLira versus IDeg, while hypoglycaemia was higher with IDegLira than liraglutide, irrespective of baseline HbA1c. In DUAL II, insulin dose and hypoglycaemia rate were similar with IDegLira and IDeg (maximum dose limited to 50 U) independent of baseline HbA1c. The reduction in HbA1c with IDegLira was independent of disease duration and previous insulin dose but varied depending on pre-trial OAD treatment.
IDegLira effectively lowered HbA1c across a range of measures, implying suitability for patients with either early or advanced T2D.
通过事后分析评估基础胰岛素德谷胰岛素与胰高血糖素样肽-1受体激动剂利拉鲁肽的新型组合(IDegLira)在2型糖尿病(T2D)患者中是否始终有效,而不考虑T2D进展阶段。
利用DUAL I扩展研究(初治患者口服抗糖尿病药物(OADs)控制不佳,n = 1660,52周)和DUAL II(基础胰岛素加OADs控制不佳的患者,n = 398,26周)随机试验的数据,研究IDegLira在疾病进展阶段指标(包括基线糖化血红蛋白(HbA1c)、病程和既往胰岛素剂量)方面的疗效。
在DUAL I中,对于四类基线HbA1c(≤7.5 - 9.0%),与单独使用德谷胰岛素或利拉鲁肽相比,IDegLira使HbA1c降低幅度更大(1.1 - 2.5%)。在DUAL II中,除最低HbA1c类别外,IDegLira使HbA1c降低幅度(0.9 - 2.5%)显著大于德谷胰岛素。在DUAL I中,与德谷胰岛素相比,在所有基线HbA1c类别中,IDegLira的胰岛素剂量和低血糖发生率更低,而无论基线HbA1c如何,IDegLira的低血糖发生率高于利拉鲁肽。在DUAL II中,IDegLira和德谷胰岛素(最大剂量限制为50 U)的胰岛素剂量和低血糖发生率与基线HbA1c无关,两者相似。IDegLira使HbA1c降低与病程和既往胰岛素剂量无关,但因试验前OAD治疗而异。
IDegLira在一系列指标上有效降低HbA1c,这意味着它适用于早期或晚期T2D患者。