Centre hospitalier universitaire La Cavale-Blanche, boulevard Tanguy-Prigent, 29600 Brest, France.
Ann Endocrinol (Paris). 2013 Dec;74(5-6):487-90. doi: 10.1016/j.ando.2013.04.004. Epub 2013 Aug 23.
Insulin degludec is a new basal insulin analogue with an ultra-long duration of action that provides a flat and stable action profile with a duration of action greater than 42 hours. Two clinical trials comparing insulin degludec and insulin glargine in basal-bolus therapy have recently been published. Both were 52-week, multicentre, randomised (3:1), treat-to-target trials in patients already using insulin. In both type 1 (n=629) and type 2 diabetes (n=1006), insulin degludec was non-inferior to insulin glargine with respect to reduction in HbA1c at 52 weeks. There were also no significant differences between treatment groups with respect to fasting plasma glucose. At similar levels of glycaemic control, however, insulin degludec was associated with lower rates of hypoglycaemia than insulin glargine. In type 1 diabetes, overall confirmed hypoglycaemia (plasma glucose concentration<3.1 mmol/L or severe episodes requiring assistance) was similar in the two treatment groups, but nocturnal confirmed hypoglycaemia (occurring from 00h01 to 05h59) was 25% lower with insulin degludec (P=0.021). In type 2 diabetes, overall confirmed hypoglycaemia was 18% lower (P=0.0359) and nocturnal confirmed hypoglycaemia was 25% lower (P=0.0399) with insulin degludec. Reductions in hypoglycaemia could reduce physicians' and patients' fears and encourage them to titrate insulin more aggressively, and to adhere more closely to treatment, with consequent better glycaemic control. The results of these trials suggest that insulin degludec has a place in the French clinical setting in basal-bolus therapy in type 1 and type 2 diabetes.
德谷胰岛素是一种新型超长效基础胰岛素类似物，作用持续时间超过 42 小时，可提供平稳、稳定的作用曲线。最近发表了两项比较德谷胰岛素和甘精胰岛素在基础-餐时胰岛素方案中的疗效的临床试验。这两项试验均为 52 周、多中心、随机（3:1）、以目标为导向的临床试验，纳入了正在使用胰岛素的患者。在 1 型（n=629）和 2 型糖尿病（n=1006）患者中，德谷胰岛素在 52 周时降低 HbA1c 的疗效不劣于甘精胰岛素。两组间空腹血糖也无显著差异。然而，在血糖控制相似的情况下，德谷胰岛素低血糖发生率低于甘精胰岛素。在 1 型糖尿病中，两组的总体确证性低血糖（血糖浓度<3.1mmol/L 或需要他人协助的严重低血糖发作）相似，但德谷胰岛素组夜间确证性低血糖（发生于 00h01 至 05h59 之间）发生率降低了 25%（P=0.021）。在 2 型糖尿病中，总体确证性低血糖发生率降低了 18%（P=0.0359），夜间确证性低血糖发生率降低了 25%（P=0.0399）。低血糖发生率降低可减少医生和患者的担忧，鼓励他们更积极地调整胰岛素剂量，更严格地坚持治疗，从而更好地控制血糖。这些试验结果表明，在法国的临床环境中，德谷胰岛素在 1 型和 2 型糖尿病的基础-餐时胰岛素方案中占有一席之地。
