Insulin degludec improves glycaemic control with lower nocturnal hypoglycaemia risk than insulin glargine in basal-bolus treatment with mealtime insulin aspart in Type 1 diabetes (BEGIN® Basal-Bolus Type 1): 2-year results of a randomized clinical trial
Insulin degludec improves glycaemic control with lower nocturnal hypoglycaemia risk than insulin glargine in basal-bolus treatment with mealtime insulin aspart in Type 1 diabetes (BEGIN® Basal-Bolus Type 1): 2-year results of a randomized clinical trial
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DOI：
10.1111/dme.12243
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发表时间：
2013-11-01
影响因子：
3.5
通讯作者：
Heller, S. R.
中科院分区：
文献类型：
--
作者：
Bode, B. W.;Buse, J. B.;Heller, S. R.
AimsThe本研究的目的是比较长期的安全性和有效性的基础胰岛素类似物，德谷胰岛素与甘精胰岛素（均与门冬胰岛素）在1型糖尿病，在2-year period.MethodsThis开放标签试验包括1年的主要试验和1年的扩展。患者随机接受每日一次德谷胰岛素或甘精胰岛素治疗，并滴定至早餐前血糖值为3.9-4.9mmol/l。结果德谷胰岛素组夜间经证实的低血糖发生率比甘精胰岛素组低25%（P=0.02）。两组间经证实的低血糖、重度低血糖和不良事件以及糖化血红蛋白和空腹血糖降低的发生率相似。尽管获得了相似的血糖控制，但与甘精胰岛素治疗的患者相比，德谷胰岛素治疗的患者使用的基础胰岛素减少12%，每日总胰岛素减少9%（P
AimsThe goal of this study was to compare the long-term safety and efficacy of the basal insulin analogue, insulin degludec with insulin glargine (both with insulin aspart) in Type1 diabetes, over a 2-year time period.MethodsThis open-label trial comprised a 1-year main trial and a 1-year extension. Patients were randomized to once-daily insulin degludec or insulin glargine and titrated to pre-breakfast plasma glucose values of 3.9-4.9mmol/l.ResultsThe rate of nocturnal confirmed hypoglycaemia was 25% lower with insulin degludec than with insulin glargine (P=0.02). Rates of confirmed hypoglycaemia, severe hypoglycaemia and adverse events, and reductions in glycated haemoglobin and fasting plasma glucose were similar between groups. Despite achieving similar glycaemic control, insulin degludec-treated patients used 12% less basal and 9% less total daily insulin than did insulin glargine-treated patients (P