Sitagliptin monotherapy has better effect on insulinogenic index than glimepiride monotherapy in Japanese patients with type 2 diabetes mellitus: a 52-week, multicenter, parallel-group randomized controlled trial.
Sitagliptin monotherapy has better effect on insulinogenic index than glimepiride monotherapy in Japanese patients with type 2 diabetes mellitus: a 52-week, multicenter, parallel-group randomized controlled trial.
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DOI：
10.1186/s13098-016-0131-y
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发表时间：
2016
影响因子：
4.8
通讯作者：
MAIKO Study group
中科院分区：
文献类型：
--
作者：
Kondo Y;Harada N;Hamasaki A;Kaneko S;Yasuda K;Ogawa E;Harashima S;Yoneda H;Fujita Y;Kitano N;Nakamura Y;Matsuo F;Shinji M;Hinotsu S;Nakayama T;Inagaki N;MAIKO Study group
用二肽基肽酶-4抑制剂西格列汀和格列美脲进行52周的单一治疗对日本2型糖尿病患者早期胰岛素分泌的影响尚不清楚。2011年2月至2013年3月，在18个中心进行了一项随机、平行分组的开放标签试验。纳入171例T2 DM门诊患者，随机分为格列美脲和西格列汀两组。格列美脲(0.25-1.0 mg/天)和西格列汀(25-100 mg/天)的剂量根据血红蛋白A1c(HbA1c)和6.9%进行了调整。对随机选择的服药对象进行全分析集(Fas)分析，并在治疗前后进行75 mg口服葡萄糖耐量试验(OGTTS)。主要结果是通过协方差分析(ANCOVA)评估治疗后早期胰岛素分泌的胰岛素分泌指数。在171名入选受试者中，西格列汀组68人和格列美脲组65人纳入Fas(平均年龄，)；基线(HbA1c)，7.4%。初步结果显示，西格列汀组的胰岛素生成指数显著高于格列美脲组(p=0.036)。与格列美脲相比，西格列汀还在OGTT期间降低了60和120分钟的血糖水平，同时在治疗期间实现了类似的HbA1c改善。两组患者的体重均无变化，格列美脲治疗组有1例出现低血糖。与格列美脲相比，西格列汀对日本2型糖尿病患者治疗52周后的胰岛素指数有更好的疗效。试验登记大学医院医学信息网(UMIN)临床试验登记，编号00004791。本文的在线版本(doi：10.1186/s13098-0160131-y)包含补充材料，可供授权用户使用。
The 52-week monotherapy with the dipeptidyl peptidase-4 inhibitor sitagliptin and the sulphonylurea glimepiride on early-phase insulin secretion in Japanese patients with type 2 diabetes mellitus (T2DM) is not known. A randomized, parallel-group, open-label trial was conducted at 18 centers between February, 2011 and March, 2013. 171 outpatients with T2DM were recruited and randomly assigned to glimepiride or sitagliptin by minimization. Doses of glimepiride (0.25–1.0 mg/day) and sitagliptin (25–100 mg/day) were adjusted for hemoglobin A1c (HbA1c) > 6.9 %. Analyses were performed on full analysis set (FAS) of randomized subjects taking medications as allocated, and underwent 75 g oral glucose tolerance test (OGTTs) before and after treatment. The primary outcome was insulinogenic index to quantify early-phase insulin secretion after treatment, which was evaluated by analysis of covariance (ANCOVA). Of 171 enrolled subjects, 68 in the sitagliptin group and 65 in the glimepiride group were included in the FAS (mean age, 64 years; baseline (HbA1c), 7.4 %). The primary outcome revealed a significantly higher insulinogenic index in the sitagliptin group than that in the glimepiride group (p = 0.036). Sitagliptin also reduced plasma glucose levels at 60 and 120 min during OGTT compared with glimepiride, while achieving a similar improvement in HbA1c during treatment. Body weight did not change in either of the two groups, and one case of hypoglycemia was observed in the glimepiride group. Sitagliptin shows better effects on insulinogenic index after 52-week treatment compared with glimepiride in Japanese patients with T2DM. Trial registration University hospital Medical Information Network (UMIN) Clinical Trials Registry, No.00004791. The online version of this article (doi:10.1186/s13098-016-0131-y) contains supplementary material, which is available to authorized users.