Zhou Wenchuan, Tao Jinxin, Zhou Xiaodong, Chen Hongxia
Department of Gastroenterology, The First Affiliated Hospital of Nanchang University, No. 17, Yongwaizheng Road, Donghu District, Nanchang, 330006, China.
Department of Clinical Medicine, The Second Clinical Medical College, Nanchang University, Nanchang, China.
Diabetes Ther. 2019 Jun;10(3):835-852. doi: 10.1007/s13300-019-0624-4. Epub 2019 Apr 24.
The purpose of this study was to compare insulin degludec with insulin glargine in terms of efficacy and safety in patients with type 2 diabetes.
We systematically searched PubMed, Embase, Web of Science, and Cochrane Library databases for randomized controlled trials published prior to 13 August 2018 (no language restrictions) which compared insulin degludec with insulin glargine. Our main endpoints were glycemic control, hypoglycemic event, weight gain, and serious adverse events (SAEs). We assessed pooled data using random-effects models.
A total of 15 studies that included 9619 patients in the insulin degludec arm of the studies and 7075 patients in the insulin glargine arm were identified and subsequently assessed. Our analysis showed that compared with insulin glargine, insulin degludec yielded an improved mean reduction in fasting plasma glucose (FPG) (weighted mean difference [WMD] - 5.20 mg/dL, 95% confidence interval [CI] - 7.34, - 3.07, P < 0.00001) and a lower ratio of participants experiencing ≥ 1 severe hypoglycemic event (relative risk [RR] 0.68, 95% CI 0.50, 0.93, P = 0.01) and nocturnal hypoglycemia (RR 0.81, 95% CI 0.75, 0.88, P < 0.0001); however, in the insulin degludec group there was a lower ratio of participants with glycated hemoglobin (HbA1c) of ≤ 7.0% (RR 0.92, 95% CI 0.86, 0.98, P = 0.01). There was no statistically significant difference between the two treatment groups for HbA1c reduction (WMD 0.03, 95% CI - 0.00, 0.07, P = 0.08), body weight gain (WMD 0.12, 95% CI - 0.19, 0.43, P = 0.46), and proportion of participants with SAEs (RR 0.97, 95% CI 0.92, 1.02, P = 0.20).
Insulin degludec and insulin glargine provide similar glycemic control, but insulin degludec also lowers the risk of hypoglycemia. Consequently, insulin degludec may be an alternative treatment for the management of patients with type 2 diabetes who are prone to hypoglycemia with insulin glargine.
本研究旨在比较德谷胰岛素与甘精胰岛素在2型糖尿病患者中的疗效和安全性。
我们系统检索了PubMed、Embase、Web of Science和Cochrane图书馆数据库，以查找2018年8月13日前发表的比较德谷胰岛素与甘精胰岛素的随机对照试验（无语言限制）。我们的主要终点是血糖控制、低血糖事件、体重增加和严重不良事件（SAEs）。我们使用随机效应模型评估汇总数据。
共识别并随后评估了15项研究，这些研究中德谷胰岛素组有9619例患者，甘精胰岛素组有7075例患者。我们的分析表明，与甘精胰岛素相比，德谷胰岛素使空腹血糖（FPG）的平均降低幅度更大（加权平均差[WMD] - 5.20mg/dL，95%置信区间[CI] - 7.34，- 3.07，P < 0.00001），且发生≥1次严重低血糖事件的参与者比例更低（相对风险[RR] 0.68，95% CI 0.50，0.93，P = 0.01）以及夜间低血糖发生率更低（RR 0.81，95% CI 0.75，0.88，P < 0.0001）；然而，德谷胰岛素组糖化血红蛋白（HbA1c）≤7.0%的参与者比例更低（RR 0.92，95% CI 0.86，0.98，P = 0.01）。两组治疗在HbA1c降低幅度（WMD 0.03，95% CI - 0.00，0.07，P = 0.08）、体重增加（WMD 0.12，95% CI - 0.19，0.43，P = 0.46）以及SAEs参与者比例（RR 0.97，95% CI 0.92，1.02，P = 0.20）方面无统计学显著差异。
德谷胰岛素和甘精胰岛素提供相似的血糖控制，但德谷胰岛素还可降低低血糖风险。因此，对于使用甘精胰岛素易发生低血糖的2型糖尿病患者，德谷胰岛素可能是一种替代治疗方法。
