Takebayashi Kohzo, Sakurai Shintaro, Suzuki Tatsuhiko, Hori Kenichiro, Terasawa Tomoko, Naruse Rika, Hara Kenji, Suetsugu Mariko, Tsuchiya Takafumi, Aoki Hiromi, Hamasaki Takashi, Shuutou Hiroshi, Inukai Toshihiko
Department of Internal Medicine, Dokkyo Medical University Koshigaya Hospital, Koshigaya, Japan.
Endocr J. 2014;61(10):1031-9. doi: 10.1507/endocrj.ej14-0208. Epub 2014 Sep 2.
The main purpose of the current study was to investigate the effect of a combination of alogliptin [a dipeptydil peptidase (DPP)-4 inhibitor] and lansoprazole [a proton pump inhibitor (PPI)] compared with alogliptin mono-therapy on glycemic control in patients with type 2 diabetes. This study was a multicenter randomized open-label study. One hundred type 2 diabetic patients were randomly assigned to either the alogliptin with lansoprazole group or the alogliptin mono-therapy group. After 3 months of treatment, the changes in hemoglobin (Hb)A1c, fasting plasma glucose (FPG), serum gastrin, homeostasis model assessment (HOMA)-β, and HOMA-insulin resistance (IR) were evaluated. A significant decrease in HbA1c and FPG, and a significant increase in HOMA-β were observed in both groups (all with P <0.0001). However, there were no significant differences in changes in HbA1c, FPG, or HOMA-β before and after therapy between the combination and alogliptin mono-therapy group (P =0.2945, P =0.1901, P =0.3042, respectively). There was a significant elevation of serum gastrin in the combination group compared with the alogliptin mono-therapy group (P =0.0004). This study showed that, although combination therapy with alogliptin and lansoprazole more effectively elevated serum gastrin levels compared with alogliptin mono-therapy, the effect of the combination therapy on glycemic control was equal to that of alogliptin mono-therapy during a 3-month study period.
本研究的主要目的是调查阿格列汀(一种二肽基肽酶-4抑制剂)与兰索拉唑(一种质子泵抑制剂)联合用药相较于阿格列汀单药治疗对2型糖尿病患者血糖控制的影响。本研究为多中心随机开放标签研究。100例2型糖尿病患者被随机分为阿格列汀联合兰索拉唑组或阿格列汀单药治疗组。治疗3个月后,评估糖化血红蛋白(Hb)A1c、空腹血糖(FPG)、血清胃泌素、稳态模型评估(HOMA)-β及HOMA胰岛素抵抗(IR)的变化。两组患者的HbA1c和FPG均显著降低,HOMA-β显著升高(均P<0.0001)。然而,联合用药组与阿格列汀单药治疗组治疗前后HbA1c、FPG或HOMA-β变化无显著差异(分别为P =0.2945、P =0.1901、P =0.3042)。与阿格列汀单药治疗组相比,联合用药组血清胃泌素显著升高(P =0.0004).本研究表明,尽管与阿格列汀单药治疗相比,阿格列汀与兰索拉唑联合治疗能更有效地提高血清胃泌素水平,但在3个月的研究期间,联合治疗对血糖控制的效果与阿格列汀单药治疗相当。