Sato Seiji, Saisho Yoshifumi, Kou Kinsei, Meguro Shu, Tanaka Masami, Irie Junichiro, Kawai Toshihide, Itoh Hiroshi
Department of Internal Medicine, Keio University School of Medicine, Tokyo, Japan.
PLoS One. 2015 Mar 27;10(3):e0121988. doi: 10.1371/journal.pone.0121988. eCollection 2015.
To clarify the efficacy and safety of adding sitagliptin to insulin therapy in Japanese patients with suboptimally controlled type 2 diabetes (T2DM).
This was a 24-week, prospective, randomized, open-labeled, controlled trial. Patients with T2DM who were suboptimally controlled despite receiving at least twice daily injection of insulin were enrolled in the study. The patients were randomized to continuation of insulin treatment (Insulin group) or addition of sitagliptin 50 to 100 mg daily to insulin treatment (Ins+Sita group). The primary outcome was change in HbA1c at week 24.
Adding sitagliptin to insulin significantly reduced HbA1c from 7.9 ± 1.0% at baseline to 7.0 ± 0.8% at week 24 (P <0.0001), while there was no significant change in HbA1c in the Insulin group (7.8 ± 0.7% vs. 7.8 ± 1.1%, P = 0.32). The difference in HbA1c reduction between the groups was 0.9% (95% confidence interval, 0.4 to 1.5, P = 0.01). There was no significant weight gain in either group. Incidence of hypoglycemia was significantly reduced in the Ins+Sita group compared with the Insulin group. Treatment satisfaction was improved in the Ins+Sita group. Baseline HbA1c level and beta cell function were associated with the magnitude of reduction in HbA1c in the Ins+Sita group.
Adding sitagliptin to insulin reduced HbA1c without weight gain or increase in hypoglycemia, and improved treatment satisfaction in Japanese patients with T2DM who were suboptimally controlled despite at least twice daily injection of insulin.
The University Hospital Medical Information Network (UMIN) Clinical Trials Registry UMIN000004678.
阐明在日本2型糖尿病（T2DM）控制不佳的患者中，在胰岛素治疗基础上加用西他列汀的疗效和安全性。
这是一项为期24周的前瞻性、随机、开放标签、对照试验。尽管每天至少注射两次胰岛素但血糖控制不佳的T2DM患者被纳入研究。患者被随机分为继续胰岛素治疗组（胰岛素组）或在胰岛素治疗基础上加用每日50至100毫克西他列汀组（胰岛素+西他列汀组）。主要结局是第24周时糖化血红蛋白（HbA1c）的变化。
在胰岛素治疗基础上加用西他列汀可使HbA1c从基线时的7.9±1.0%显著降至第24周时的7.0±0.8%（P<0.0001），而胰岛素组的HbA1c无显著变化（7.8±0.7%对7.8±1.1%，P=0.32）。两组间HbA1c降低幅度的差异为0.9%（95%置信区间，0.4至1.5，P=0.01）。两组均无显著体重增加。与胰岛素组相比，胰岛素+西他列汀组低血糖发生率显著降低。胰岛素+西他列汀组治疗满意度得到改善。基线HbA1c水平和β细胞功能与胰岛素+西他列汀组HbA1c降低幅度相关。
在胰岛素治疗基础上加用西他列汀可降低HbA1c，且不增加体重或低血糖发生率，并改善了尽管每天至少注射两次胰岛素但血糖控制不佳的日本T2DM患者的治疗满意度。
大学医院医学信息网络（UMIN）临床试验注册中心UMIN000004678 。
