德谷胰岛素和甘精胰岛素对1型糖尿病患者日常空腹血糖变异性的影响：一项多中心、随机、交叉研究。
Effects of insulin degludec and insulin glargine on day-to-day fasting plasma glucose variability in individuals with type 1 diabetes: a multicentre, randomised, crossover study.
作者信息
Nakamura Tomoaki, Sakaguchi Kazuhiko, So Anna, Nakajima Shinsuke, Takabe Michinori, Komada Hisako, Okuno Yoko, Hirota Yushi, Nakamura Takehiro, Iida Keiji, Kajikawa Michiko, Nagata Masao, Ogawa Wataru, Seino Susumu
机构信息
Division of Diabetes and Endocrinology, Department of Internal Medicine, Kobe University Graduate School of Medicine, 7-5-1 Kusunoki-cho, Chuo-ku, Kobe, 650-0017, Japan.
出版信息
Diabetologia. 2015 Sep;58(9):2013-9. doi: 10.1007/s00125-015-3648-y. Epub 2015 Jun 5.
AIMS/HYPOTHESIS: We compared the effects of insulin degludec (IDeg; Des(B30)LysB29(γ-Glu Nε-hexadecandioyl) human insulin) and insulin glargine (IGlar; A21Gly,B31Arg,B32Arg human insulin) on the day-to-day variability of fasting plasma glucose (FPG) levels in individuals with type 1 diabetes treated with basal-bolus insulin injections.
METHODS
The effects of basal-bolus insulin therapy for 4 weeks with either IDeg or IGlar as the basal insulin in adult C-peptide-negative outpatients with type 1 diabetes were investigated in an open-label, multicentre, randomised, crossover trial. Randomisation was conducted using a centralised allocation process. The primary endpoints were the SD and CV of FPG during the final week of each treatment period. Secondary endpoints included serum glycoalbumin level, daily dose of insulin, intraday glycaemic variability and frequency of severe hypoglycaemia.
RESULTS
Thirty-six randomised participants (17 in the IDeg/IGlar and 19 in the IGlar/IDeg groups) were recruited, and data for 32 participants who completed the trial were analysed. The mean (7.74 ± 1.76 vs 8.56 ± 2.06 mmol/l; p = 0.04) and SD (2.60 ± 0.97 vs 3.19 ± 1.36 mmol/l; p = 0.03) of FPG were lower during IDeg treatment than during IGlar treatment, whereas the CV did not differ between the two treatments. The dose of IDeg was smaller than that of IGlar (11.0 ± 5.2 vs 11.8 ± 5.6 U/day; p < 0.01), but other secondary endpoints did not differ between the treatments.
CONCLUSIONS/INTERPRETATION: IDeg yielded a lower FPG level and smaller day-to-day variability of FPG at a lower daily dose compared with IGlar in participants with type 1 diabetes. IDeg serves as a good option for basal insulin in the treatment of type 1 diabetes.
TRIAL REGISTRATION
University Hospital Medical Information Network 000009965.
FUNDING
This research recieved no specific grant from any funding agency in the public, commercial or not-for-profit sectors.
目的/假设：我们比较了德谷胰岛素（IDeg；Des（B30）LysB29（γ-谷氨酸Nε-十六烷二酰）人胰岛素）和甘精胰岛素（IGlar；A21Gly，B31Arg，B32Arg人胰岛素）对接受基础-餐时胰岛素注射治疗的1型糖尿病患者空腹血糖（FPG）水平日常变异性的影响。
方法
在一项开放标签、多中心、随机、交叉试验中，研究了以IDeg或IGlar作为基础胰岛素进行4周基础-餐时胰岛素治疗对成年C肽阴性1型糖尿病门诊患者的影响。随机分组采用集中分配程序。主要终点是每个治疗期最后一周FPG的标准差（SD）和变异系数（CV）。次要终点包括血清糖化白蛋白水平、胰岛素日剂量、日内血糖变异性和严重低血糖发生频率。
结果
招募了36名随机分组的参与者（IDeg/IGlar组17名，IGlar/IDeg组19名），并对32名完成试验的参与者的数据进行了分析。与IGlar治疗期间相比，IDeg治疗期间FPG的平均值（7.74±1.76 vs 8.56±2.06 mmol/l；p = 0.04）和SD（2.60±0.97 vs 3.19±1.36 mmol/l；p = 0.03）较低，而两种治疗之间的CV没有差异。IDeg的剂量低于IGlar（11.0±5.2 vs 11.8±5.6 U/天；p < 0.01），但其他次要终点在两种治疗之间没有差异。
结论/解读：在1型糖尿病患者中，与IGlar相比，IDeg在较低日剂量时FPG水平更低，且FPG的日常变异性更小。IDeg是1型糖尿病治疗中基础胰岛素的一个良好选择。
试验注册
大学医院医学信息网络000009965。
资金来源
本研究未获得公共、商业或非营利部门任何资助机构的特定资助。
Zotero 插件