Institute of Cellular Medicine - Diabetes, Newcastle University, Newcastle upon Tyne, UK.
Diabetes Res Clin Pract. 2011 Dec;94(3):352-63. doi: 10.1016/j.diabres.2011.10.021.
The aim of A(1)chieve was to remedy the deficit of data on the efficacy and safety of insulin analogues in routine clinical care in less well-resourced/newly developed countries.
A non-interventional, 6-month, observational study of 66,726 people with type 2 diabetes, both insulin users and non-insulin users, started on insulin detemir, insulin aspart or biphasic insulin aspart in 28 countries across four continents.
Baseline HbA(1c) (±SD) was poor: 9.5 ± 1.8%. At 6 months, improvement was -2.1 ± 1.7% in the entire cohort, and -2.2 ± 1.7% and -1.8 ± 1.7% for prior non-insulin users and insulin users. All three analogue therapies gave similar results, again independently of prior insulin use, but also from seven pre-specified country groupings. Overall, hypoglycaemia did not increase in those new to insulin, and fell in those switching insulins. There was no change in body weight (-0.1 ± 3.7 kg), while lipid profile and systolic blood pressure (-6.3 ± 17.1 mmHg) were improved.
Beginning insulin analogue therapy in people with type 2 diabetes and poor blood glucose control is associated with marked improvements in diverse aspects of vascular risk factor profile without evidence of clinically significant safety or tolerability problems.
A(1)chieve 研究旨在弥补资源较少/新开发国家常规临床护理中关于胰岛素类似物疗效和安全性数据的不足。
这是一项非干预性、6 个月、观察性研究，共纳入来自四大洲 28 个国家的 66726 名 2 型糖尿病患者（包括胰岛素使用者和非胰岛素使用者），他们起始使用地特胰岛素、门冬胰岛素或门冬胰岛素 30。
基线 HbA(1c)（±SD）较差：9.5 ± 1.8%。在 6 个月时，整个队列的 HbA(1c)改善了-2.1 ± 1.7%，而既往未使用胰岛素者和胰岛素使用者的改善幅度分别为-2.2 ± 1.7%和-1.8 ± 1.7%。三种类似物治疗均取得了相似的结果，与既往是否使用胰岛素无关，但与七个预先指定的国家分组有关。总体而言，新起始胰岛素治疗者的低血糖事件并未增加，而转换胰岛素治疗者的低血糖事件减少。体重无变化（-0.1 ± 3.7 kg），而血脂谱和收缩压（-6.3 ± 17.1 mmHg）得到改善。
对于血糖控制不佳的 2 型糖尿病患者起始胰岛素类似物治疗，与血管危险因素谱的多个方面显著改善相关，且无临床显著安全性或耐受性问题的证据。
