Efficacy and safety of saxagliptin in combination with insulin in Japanese patients with type 2 diabetes mellitus: a 16-week double-blind randomized controlled trial with a 36-week open-label extension

Background: We examined the efficacy and safety of saxagliptin as an add-on to insulin in Japanese patients with type 2 diabetes mellitus. Research design and methods: We randomized 240 patients with type 2 diabetes mellitus on insulin monotherapy to 5-mg saxagliptin or placebo as add-on therapy for a 16-week, double-blind period. All patients received 5-mg saxagliptin and insulin for an additional 36 weeks (open-label extension). Change in hemoglobin A1c (HbA1c) at Week 16 was the main endpoint. Results: At Week 16, the adjusted change in HbA1c from baseline increased by 0.51% with placebo and decreased by 0.40% with saxagliptin (difference −0.92% [95% confidence interval −1.07%, −0.76%; p Conclusions: Adding saxagliptin to ongoing insulin therapy improved glycemic control and was well tolerated in Japanese patients with type 2 diabetes.

背景：本研究探讨沙格列汀 (saxagliptin) 作为胰岛素附加治疗方案，用于日本2型糖尿病 (type 2 diabetes mellitus) 患者的有效性与安全性。
研究设计与方法：本研究将240例接受胰岛素单药治疗 (insulin monotherapy) 的2型糖尿病患者随机分为两组，分别给予5mg沙格列汀或安慰剂作为附加治疗，开展为期16周的双盲 (double-blind) 阶段研究。所有患者后续均接受5mg沙格列汀联合胰岛素治疗，完成额外36周的开放标签扩展阶段 (open-label extension)。第16周时糖化血红蛋白 (hemoglobin A1c, HbA1c) 较基线的变化值为本次研究的主要终点 (main endpoint)。
结果：第16周时，安慰剂组患者的糖化血红蛋白校正后较基线变化值升高0.51%，沙格列汀组则降低0.40%，组间差值为-0.92%[95%置信区间 (confidence interval)：-1.07% ~ -0.76%；P]。
结论：在日本2型糖尿病患者中，于现行胰岛素治疗方案基础上加用沙格列汀可改善血糖控制 (glycemic control)，且耐受性良好。