Department of Endocrinology and Metabolism, Kangbuk Samsung Hospital, Sungkyunkwan University School of Medicine, Seoul, Republic of Korea.
Department of Internal Medicine, Severance Hospital, University of Yonsei University College of Medicine, Seoul, Republic of Korea.
Diabetes Obes Metab. 2017 Jun;19(6):892-896. doi: 10.1111/dom.12869. Epub 2017 Mar 16.
The aim of this study was to evaluate the effect of gemigliptin vs sitagliptin or glimepiride as initial combination therapy with metformin on glycaemic variability and to assess the correlation between glycaemic variability reduction and the dipeptidyl peptidase-4 (DPP-4) inhibition in patients with type 2 diabetes. This multicentre, randomized, active-controlled, open-label exploratory study included 69 patients with HbA1c > 7.5%. Subjects were randomized to receive gemigliptin 50 mg (n = 24), sitagliptin 100 mg (n = 23) or glimepiride 2 mg (n = 22) for 12 weeks. After 12 weeks, the change in mean amplitude of glycaemic excursion (MAGE) compared with baseline was significantly lower in the DPP-4 inhibitor groups compared with that in patients who received glimepiride. Furthermore, the standard deviation (SD) of glucose was significantly lower in patients who received gemigliptin than that in patients who received sitagliptin or glimepiride. The DPP-4 inhibition was significantly correlated with changes in MAGE and SD of glucose. In conclusion, gemigliptin and sitagliptin were more effective than glimepiride in reducing glycaemic variability as initial combination therapy with metformin in patients with type 2 diabetes, and the DPP-4 inhibition was associated with a reduction in glycaemic variability.
本研究旨在评估与二甲双胍联合使用时，相较于西格列汀或格列美脲，吉马列汀作为初始联合治疗方案对血糖变异性的影响，并评估 2 型糖尿病患者血糖变异性降低与二肽基肽酶-4（DPP-4）抑制之间的相关性。这是一项多中心、随机、活性对照、开放标签的探索性研究，纳入了 69 名糖化血红蛋白（HbA1c）>7.5%的患者。患者被随机分为吉马列汀 50mg 组（n=24）、西格列汀 100mg 组（n=23）或格列美脲 2mg 组（n=22），治疗 12 周。12 周后，与基线相比，DPP-4 抑制剂组的平均血糖波动幅度（MAGE）的变化明显低于格列美脲组。此外，与接受西格列汀或格列美脲治疗的患者相比，接受吉马列汀治疗的患者的血糖标准差（SD）明显更低。DPP-4 抑制与 MAGE 和血糖 SD 的变化显著相关。总之，与格列美脲相比，吉马列汀和西格列汀作为与二甲双胍联合使用的初始联合治疗方案，在降低 2 型糖尿病患者的血糖变异性方面更有效，且 DPP-4 抑制与血糖变异性降低相关。
