Davies M, Sasaki T, Gross J L, Bantwal G, Ono Y, Nishida T, Tojjar D, Seino H
Diabetes Research Centre, Leicester General Hospital, University of Leicester, Leicester, UK.
Internal Medicine, Sasaki Hospital Internal Medicine, Hokkaido, Japan.
Diabetes Obes Metab. 2016 Jan;18(1):96-9. doi: 10.1111/dom.12573. Epub 2015 Oct 19.
The long-term safety and tolerability of insulin degludec (IDeg) was compared with that of insulin detemir (IDet), as basal treatment in participants with type 1 diabetes mellitus (T1DM). In the present multinational, 26-week core + 26-week extension, controlled, open-label, parallel-group trial, adults with T1DM were randomized to IDeg or IDet as basal insulin treatment combined with meal-time bolus insulin aspart. IDeg was administered once daily, whilst IDet was administered once or twice daily depending on patients' glycaemic control. After 1 year, IDeg provided a 33% lower rate of nocturnal hypoglycaemia compared with IDet: estimated rate ratio (IDeg : IDet) 0.67 [95% confidence interval (CI) 0.51; 0.88]; p < 0.05. IDeg improved glycated haemoglobin after 1 year of treatment, similarly to IDet, but IDeg also provided a significantly greater reduction in fasting plasma glucose compared with IDet: estimated difference (IDeg - IDet) -1.11 (95% CI -1.83; -0.40) mmol/l; p < 0.05. The present study confirmed the long-term safety and tolerability profile of IDeg in patients with T1DM. IDeg provided a lower risk of nocturnal confirmed hypoglycaemia than IDet.
将德谷胰岛素（IDeg）与地特胰岛素（IDet）作为1型糖尿病（T1DM）患者的基础治疗药物，比较二者的长期安全性和耐受性。在这项跨国、为期26周核心期+26周延长期、对照、开放标签、平行组试验中，成年T1DM患者被随机分为接受IDeg或IDet作为基础胰岛素治疗，并联合餐时门冬胰岛素推注治疗。IDeg每日给药一次，而IDet根据患者血糖控制情况每日给药一次或两次。1年后，与IDet相比，IDeg夜间低血糖发生率降低33%：估计率比（IDeg∶IDet）为0.67[95%置信区间（CI）0.51；0.88]；p＜0.05。治疗1年后，IDeg改善糖化血红蛋白的效果与IDet相似，但与IDet相比，IDeg使空腹血糖显著降低更多：估计差值（IDeg - IDet）为-1.11（95% CI -1.83；-0.40）mmol/L；p＜0.05。本研究证实了IDeg在T1DM患者中的长期安全性和耐受性。与IDet相比，IDeg夜间确诊低血糖风险更低。
