Efficacy and safety of sitagliptin treatment in older adults with moderately controlled type 2 diabetes: the STREAM study

作者：Mototsugu Nagao, Junichi Sasaki, Hitoshi Sugihara, Kyoko Tanimura‐Inagaki, Taro Harada, Ichiro Sakuma, Shinichi Oikawa, STREAM Study Investigators, Toshiaki Asano, S. Aoyama, Takeshi Fukushima, J. Yan, Osamu Hasegawa, Kohei Thi Hosokawa, Yasuji Ishimaru, Hiroshi Kaito, Reibun Kanbara, K. Kanno, Kyosuke Kimura, Shigeki Moritani, Tomohiro Okuda, Minoru Okuma, Takahide Okumura, Hiromasa Omuro, Yasunori Sawayama, Hideki Shuto, Junichi Tanaka, Tomohiro Tada, Kunihiko Tateoka, Tomoyuki Terada, Hiroshi Tsuzuki, M. Yamada · 发表于：Scientific Reports · 年份：2023 · DOI：10.1038/s41598-022-27301-9 · 被引用次数：41 · 研究领域：Diabetes Treatment and Management、Pharmacology and Obesity Treatment、Diabetes Management and Research

Sitagliptin has been suggested as a treatment option for older adults with type 2 diabetes (T2D). However, no randomized controlled trial has been performed to evaluate the efficacy and safety of sitagliptin treatment in older Japanese patients with T2D. The STREAM study was a multicenter, open-label, randomized controlled trial. T2D outpatients aged 65-80 years with moderately controlled glycemic levels (HbA1c 7.4-10.4%) under lifestyle interventions without or with oral anti-diabetic drugs excluding DPP4 inhibitors or GLP-1 receptor agonists were recruited (n = 176). The participants were randomized into sitagliptin group (n = 88) who received sitagliptin as an initial or an additive anti-diabetic drug and control group (n = 88) who did not. The treatment goal was HbA1c level < 7.4%. Efficacy and safety during 12-month treatment period were investigated. The mean (± SD) ages were 70.6 ± 3.9 and 71.9 ± 4.4 years old in sitagliptin and control groups, respectively. According to a mixed-effects model analysis, average changes from baseline over the treatment period in fasting plasma glucose (FPG), HbA1c, and glycated albumin (GA) were - 27.2 mg/dL, - 0.61%, and - 2.39%, respectively, in sitagliptin group, and 0.50 mg/dL, - 0.29%, and - 0.93%, respectively, in control group. The reductions in FPG, HbA1c, and GA were significantly greater in sitagliptin group (P < 0.0001, P < 0.01, and P < 0.0001, respectively). There were no differences in the incidence of adverse effects, exce...