Exenatide compared with long-acting insulin to achieve glycaemic control with minimal weight gain in patients with type 2 diabetes: results of the Helping Evaluate Exenatide in patients with diabetes compared with Long-Acting insulin (HEELA) study
Exenatide compared with long-acting insulin to achieve glycaemic control with minimal weight gain in patients with type 2 diabetes: results of the Helping Evaluate Exenatide in patients with diabetes compared with Long-Acting insulin (HEELA) study
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DOI：
10.1111/j.1463-1326.2009.01154.x
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发表时间：
2009-12-01
影响因子：
5.8
通讯作者：
Kilcoyne, A.
中科院分区：
文献类型：
--
作者：
Davies, M. J.;Donnelly, R.;Kilcoyne, A.
目的：与长效胰岛素（HEELA）相比，在超重糖尿病患者中帮助评估艾塞那肽（exenglutamine）研究旨在检查胰高血糖素样肽-1（GLP-1）受体激动剂艾塞那肽（exenglutamine），改善HbA 1c（< 7.4%），与甘精胰岛素相比体重增加最小（< 1 kg）。心血管风险升高和2型糖尿病经两种或三种口服降糖药（OAD）控制不佳的患者被随机分配至加用艾司那肽5-10 μ g b.i.d.组。（n = 118）或甘精胰岛素o.d.（滴定至目标空腹血糖< 5.6 mmol/l; n = 117）26周。年龄为56.5（9.1）岁，BMI为34.1（5.3）kg/m2，58.5%的患者正在服用两种OAD。艾塞那肽组和甘精胰岛素组的平均基线HbA 1c分别为8.65（0.68）%和8.48（0.66）%。艾塞那肽组达到HbA 1c < 7.4%且体重增加< 1 kg复合终点的患者比例为53.4%，甘精胰岛素组为19.8%（艾塞那肽与甘精胰岛素相比，p < 0.001）。艾塞那肽和甘精胰岛素在HbA 1c改善方面未表现出显著差异[最小二乘（LS）均值[s.e.m.]：-1.25 [0.09]%和-1.26 [0.09]%; p = 0.924]，但在26周后对体重的影响不同（分别为-2.73 [0.31]和+2.98 [0.31] kg，p < 0.001）。有更多的治疗相关的不良事件与exenlavin，但夜间低血糖的发生率较低，在整体或严重的低血糖无差异，ConclusionsAdditional治疗exenlavin导致显着更多的超重和肥胖患者心血管风险升高和2型糖尿病实现更好的血糖控制与最小的体重增加相比，甘精胰岛素。
AimThe Helping Evaluate Exenatide in overweight patients with diabetes compared with Long-Acting insulin (HEELA) study was designed to examine whether the glucagon-like peptide-1 (GLP-1) receptor agonist, exenatide, could improve HbA1c (< 7.4%) with minimal weight gain (< 1 kg) compared with insulin glargine.MethodsPatients [body mass index (BMI) > 27 kg/m2] with elevated cardiovascular risk and type 2 diabetes inadequately controlled on two or three oral antidiabetes drugs (OADs) were randomized to add-on exenatide 5-10 mu g b.i.d. (n = 118) or insulin glargine o.d. (titrated to target fasting plasma glucose < 5.6 mmol/l; n = 117) for 26 weeks.ResultsThe study population had baseline mean (s.d.) age of 56.5 (9.1) years and BMI of 34.1 (5.3) kg/m2, and 58.5% of patients were taking two OADs. Mean baseline HbA1c was 8.65 (0.68)% in the exenatide group and 8.48 (0.66)% in the insulin glargine group. The proportions of patients achieving the composite endpoint of HbA1c < 7.4% with weight gain < 1 kg were 53.4% for the exenatide group and 19.8% for the insulin glargine group (p < 0.001 for exenatide vs. insulin glargine). Exenatide and insulin glargine did not demonstrate a significant difference in HbA1c improvements [least square (LS) mean [s.e.m.]: -1.25 [0.09]% and -1.26 [0.09]% respectively; p = 0.924], but had divergent effects on body weight (-2.73 [0.31] vs. +2.98 [0.31] kg respectively, p < 0.001) after 26 weeks. There were more treatment-related adverse events with exenatide but a lower incidence of nocturnal hypoglycaemia, with no differences in overall or severe hypoglycaemia.ConclusionsAdditional treatment with exenatide resulted in significantly more overweight and obese patients with an elevated cardiovascular risk and type 2 diabetes achieving better glycaemic control with minimal weight gain compared with insulin glargine.