Endocr Pract. 2019 Apr;25(4):306-314. doi: 10.4158/EP-2018-0177.
Characterize the effectiveness of insulin glargine alone, exenatide alone, or combined in subjects taking stable doses of metformin and evaluate their impact on hemoglobin A1C, hypoglycemia, weight, and glucose variability. Open-label, randomized, parallel-arm study of adults with type 2 diabetes naïve to both insulin and glucagon-like peptide 1 (GLP-1) agonist who were not at A1C goal despite treatment with metformin. This prospective interventional study employed blinded continuous glucose monitoring ambulatory glucose profile (AGP) reports over 32 weeks. Subjects were randomized to treatment with glargine (Iglar), exenatide (GLP-1), or combination of glargine and exenatide (Iglar + GLP-1). At midpoint, those not at A1C target had the second medication added; those on Iglar + GLP-1 continued therapy optimization. Decreases in A1C were: 7.6 to 6.2% for Iglar + GLP-1, 7.5 to 6.6% for Iglar, and 7.5 to 6.4% for GLP-1. Iglar + GLP-1 achieved A1C targets faster (14 to 16 weeks) but had more hypoglycemia. Hypoglycemia rates increased slightly for all arms. Weight loss was achieved in all regimens including GLP-1. Glucose variability was not reduced to the same extent in the Iglar arm as the GLP-1 arm. Addition of Iglar and/or GLP-1 to metformin for patients not at treatment goal was safe and effective. The order of medication addition needs to consider individualized AGP patterns and goals. Iglar + GLP-1 resulted in rapid A1C lowering, whereas GLP-1 was noted to have less hypoglycemia. Weight loss was most pronounced in GLP-1 monotherapy, suggesting that GLP-1 may mitigate the weight gain of Iglar. Any treatment with GLP-1 showed significant decreases in glucose variability. = hemoglobin A1c; = ambulatory glucose profile; = continuous glucose monitoring; = general linear model; = glucagon-like peptide 1 (exenatide); = insulin glargine; = sodium-glucose cotransporter 2; = self-monitoring blood glucose; = sulfonylurea; = type 2 diabetes mellitus.
描述甘精胰岛素单药、艾塞那肽单药或联合治疗在稳定剂量使用二甲双胍的患者中的有效性，并评估其对糖化血红蛋白（HbA1C）、低血糖、体重和血糖变异性的影响。这是一项针对初治胰岛素和胰高血糖素样肽 1（GLP-1）激动剂的 2 型糖尿病成人的开放性、随机、平行臂研究，这些患者尽管接受了二甲双胍治疗，但仍未达到 HbA1C 目标。这项前瞻性干预性研究采用了连续血糖监测的盲法动态血糖监测（AGP）报告，持续 32 周。受试者被随机分配接受甘精胰岛素（Iglar）、艾塞那肽（GLP-1）或甘精胰岛素和艾塞那肽联合治疗（Iglar + GLP-1）。在中点时，那些未达到 A1C 目标的患者加用第二种药物；那些接受 Iglar + GLP-1 治疗的患者继续优化治疗。HbA1C 下降幅度为：Iglar + GLP-1 组从 7.6%降至 6.2%，Iglar 组从 7.5%降至 6.6%，GLP-1 组从 7.5%降至 6.4%。Iglar + GLP-1 更快达到 A1C 目标（14-16 周），但低血糖发生率更高。所有治疗组的低血糖发生率均略有增加。所有治疗方案均实现了体重减轻，包括 GLP-1。甘精胰岛素组的血糖变异性没有像 GLP-1 组那样显著降低。对于未达到治疗目标的患者，在二甲双胍的基础上加用 Iglar 和/或 GLP-1 是安全有效的。药物添加的顺序需要考虑个体化的 AGP 模式和目标。Iglar + GLP-1 可迅速降低 HbA1C，而 GLP-1 低血糖发生率较低。GLP-1 单药治疗的体重减轻最为明显，提示 GLP-1 可能减轻 Iglar 的体重增加。任何 GLP-1 治疗均显著降低血糖变异性。
