Lim Soo, Han Kyung Ah, Yu JaeMyung, Chamnan Parinya, Kim Eun Sook, Yoon Kun-Ho, Kwon Sam, Moon Min Kyong, Lee Kwan Woo, Kim Dong-Jun, Kim Mikyung, Wongtanate Manaj, Kim Eun Young, Kim Sung-Ho, Lee Moon-Kyu
Department of Internal Medicine, Seoul National University College of Medicine, Seoul National University Bundang Hospital, Seongnam, Korea.
Department of Internal Medicine, Eulji University School of Medicine, Seoul, Korea.
Diabetes Obes Metab. 2017 Jan;19(1):87-97. doi: 10.1111/dom.12787. Epub 2016 Oct 14.
Gemigliptin is a new dipeptidyl peptidase-IV inhibitor. We investigated the efficacy and safety of initial combination therapy with gemigliptin and metformin compared with monotherapy with either drug in patients with type 2 diabetes (T2D).
A total of 433 T2D patients with a glycosylated haemoglobin (HbA1c) level of 7.5% to 11.0% and a fasting plasma glucose (FPG) concentration <270 mg/dL were randomly assigned to 3 groups: (1) gemigliptin 50 mg qd + metformin 1000 to 2000 mg qd (titrated individually), (2) gemigliptin 50 mg qd, or (3) metformin 1000 to 2000 mg qd. The primary end-point was the change in HbA1c level after 24 weeks. Secondary end-points were the changes in FPG, insulin, proinsulin and C-peptide levels. The percentages of responders who achieved an HbA1c level <7% (or <6.5%) were compared between treatment groups.
Baseline HbA1c levels were 8.7% in all groups. The mean changes in HbA1c level from baseline to week 24 were -2.06%, -1.24% and -1.47% in the combination, gemigliptin monotherapy and metformin monotherapy groups, respectively. The 95% confidence intervals for between-group differences in HbA1c changes were -1.02 to -0.63 in the combination group vs the gemigliptin group and -0.82 to -0.41 vs the metformin group, which confirmed the superiority of combination therapy. A significantly higher percentage of patients in the combination therapy group reached the target HbA1c level <7% (or <6.5%) compared with the monotherapy groups. No severe side effects were observed.
In T2D patients, the initial combination of gemigliptin and metformin had superior efficacy without safety concerns compared with monotherapy with either drug.
吉格列汀是一种新型二肽基肽酶 - Ⅳ抑制剂。我们研究了吉格列汀与二甲双胍初始联合治疗相较于单药治疗在2型糖尿病（T2D）患者中的疗效和安全性。
总共433例糖化血红蛋白（HbA1c）水平为7.5%至11.0%且空腹血糖（FPG）浓度<270mg/dL的T2D患者被随机分为3组：（1）吉格列汀50mg每日一次 + 二甲双胍1000至2000mg每日一次（个体化滴定），（2）吉格列汀50mg每日一次，或（3）二甲双胍1000至2000mg每日一次。主要终点是24周后HbA1c水平的变化。次要终点是FPG、胰岛素、胰岛素原和C肽水平的变化。比较各治疗组中达到HbA1c水平<7%（或<6.5%）的应答者百分比。
所有组的基线HbA1c水平均为8.7%。联合治疗组、吉格列汀单药治疗组和二甲双胍单药治疗组从基线到第24周HbA1c水平的平均变化分别为 -2.06%、-1.24%和 -1.47%。联合治疗组与吉格列汀组之间HbA1c变化的组间差异的95%置信区间为 -1.02至 -0.63，与二甲双胍组相比为 -0.82至 -0.41，这证实了联合治疗的优越性。与单药治疗组相比，联合治疗组中达到目标HbA1c水平<7%（或<6.5%）的患者百分比显著更高。未观察到严重副作用。
在T2D患者中，与单药治疗相比，吉格列汀与二甲双胍的初始联合治疗具有更好的疗效且无安全性问题。
