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胰岛素德谷胰岛素对比甘精胰岛素对初诊 2 型糖尿病日本患者血糖控制及日间空腹血糖变异性的影响:I'D GOT 试验。

Effect of insulin degludec versus insulin glargine on glycemic control and daily fasting blood glucose variability in insulin-naïve Japanese patients with type 2 diabetes: I'D GOT trial.

机构信息

Department of Endocrinology and Metabolism, Dokkyo Medical University, Mibu, Tochigi, Japan.

Department of Endocrinology and Metabolism, Dokkyo Medical University, Mibu, Tochigi, Japan.

出版信息

Diabetes Res Clin Pract. 2017 Aug;130:237-243. doi: 10.1016/j.diabres.2017.06.007. Epub 2017 Jun 15.

Abstract

AIMS

Insulin degludec (IDeg) is an ultra-long-acting insulin that has a smooth time/action profile over more than 42h. The present study compared the effects of IDeg and insulin glargine (IGlar) on HbA1c reduction and on within-subject day-to-day variability of fasting blood glucose (FBG) in insulin-naïve patients with type 2 diabetes.

SUBJECTS AND METHODS

Eligible patients were randomly allocated at a 3:1 ratio to receive once-daily IDeg (n=31) or IGlar (n=12). Both basal insulins were administered before breakfast and titrated to achieve a target FBG <110mg/dl. The primary endpoints were the change in HbA1c from baseline to 24weeks of treatment, as well as the standard deviation (SD) and coefficient of variation (CV) of FBG from 8 to 12weeks and from 20 to 24weeks. Secondary endpoints included the QOL evaluated by the Diabetes Therapy-Related QOL questionnaire.

RESULTS

After 24weeks, HbA1c was decreased by 1.6% in the IDeg group and 1.7% in the IGlar at the same insulin dosage. At 24weeks, FBG was significantly lower in the IDeg group than in the IGlar group and the CV of FBG was significantly smaller in the IDeg group. The frequency of total and severe hypoglycemic episodes did not differ between the groups. In the IDeg group, QOL showed significant improvement regarding anxiety and dissatisfaction with treatment.

CONCLUSIONS

Treatment with IDeg or IGlar achieved similar improvement in glycemic control in insulin-naïve patients with type 2 diabetes. The day-to-day variation of FBG was smaller in patients receiving IDeg.

摘要

目的

德谷胰岛素(IDeg)是一种超长效胰岛素,其作用时间/效应曲线在超过 42 小时内平稳。本研究比较了 IDeg 和甘精胰岛素(IGlar)在初治 2 型糖尿病患者中降低 HbA1c 以及空腹血糖(FBG)日内变异性的作用。

受试者和方法

合格的患者以 3:1 的比例随机分配接受每日一次 IDeg(n=31)或 IGlar(n=12)治疗。两种基础胰岛素均在早餐前给药,并滴定至目标 FBG<110mg/dl。主要终点是治疗 24 周时 HbA1c 的变化,以及从第 8 周到第 12 周和从第 20 周到第 24 周 FBG 的标准差(SD)和变异系数(CV)。次要终点包括通过糖尿病治疗相关生活质量问卷评估的生活质量。

结果

在 24 周时,IDeg 组的 HbA1c 降低了 1.6%,IGlar 组降低了 1.7%,且胰岛素剂量相同。在 24 周时,IDeg 组的 FBG 显著低于 IGlar 组,IDeg 组的 FBG CV 显著较小。两组之间总及严重低血糖事件的发生频率无差异。在 IDeg 组,焦虑和对治疗的不满等方面的生活质量显著改善。

结论

在初治 2 型糖尿病患者中,IDeg 或 IGlar 治疗均能显著改善血糖控制。接受 IDeg 治疗的患者 FBG 的日内变化较小。

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