沙格列汀联合胰岛素治疗日本2型糖尿病患者的疗效与安全性：一项为期16周的双盲随机对照试验及36周的开放标签延长期试验
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.
作者信息
Kadowaki Takashi, Muto Satsuki, Ouchi Yoshiumi, Shimazaki Ryutaro, Seino Yutaka
机构信息
a Department of Diabetes and Metabolic Diseases, Graduate School of Medicine , The University of Tokyo , Tokyo , Japan.
b R&D Division , Kyowa Hakko Kirin Co., Ltd ., Tokyo , Japan.
出版信息
Expert Opin Pharmacother. 2017 Dec;18(18):1903-1919. doi: 10.1080/14656566.2017.1379990. Epub 2017 Oct 12.
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 < 0.001]). In patients receiving saxagliptin, reductions in HbA1c at Week 16 were maintained to Week 52, while switching from placebo to saxagliptin resulted in a similar reduction in HbA1c. The incidence of hypoglycemia was not markedly increased with saxagliptin versus placebo in the double-blind period and did not increase substantially during the open-label extension period. The efficacy and safety of saxagliptin was similar between the elderly and non-elderly patient groups.
CONCLUSIONS
Adding saxagliptin to ongoing insulin therapy improved glycemic control and was well tolerated in Japanese patients with type 2 diabetes.
背景
我们研究了沙格列汀作为胰岛素附加治疗药物在日本2型糖尿病患者中的疗效和安全性。
研究设计与方法
我们将240例接受胰岛素单药治疗的2型糖尿病患者随机分为两组，分别接受5毫克沙格列汀或安慰剂作为附加治疗，为期16周的双盲期。所有患者在接下来的36周内接受5毫克沙格列汀和胰岛素治疗（开放标签延长期）。第16周时糖化血红蛋白（HbA1c）的变化是主要终点。
结果
在第16周时，安慰剂组HbA1c从基线的调整变化增加了0.51%，沙格列汀组降低了0.40%（差异为-0.92%[95%置信区间-1.07%，-0.76%；p<0.001]）。接受沙格列汀治疗的患者中，第16周时HbA1c的降低持续到第52周，而从安慰剂转换为沙格列汀导致HbA1c有类似程度的降低。在双盲期，与安慰剂相比，沙格列汀组低血糖发生率没有明显增加，在开放标签延长期也没有大幅增加。老年和非老年患者组中沙格列汀的疗效和安全性相似。
结论
在现有的胰岛素治疗中添加沙格列汀可改善血糖控制，并且在日本2型糖尿病患者中耐受性良好。
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