西格列汀联合地特胰岛素应用于二甲双胍控制不佳的2型糖尿病患者的临床疗效及安全性  

Clinical Efficacy and Safety of Sitagliptin Combined with Insulin Detemir in the Treatment of Type 2 Diabetes Poorly Controlled by Metformin

作　　者：李园园[1] 王旭光[2] 孙凤娟[2] 

机构地区：[1]济南大学山东省医学科学院医学与生命科学学院,山东济南250062 [2]山东医学科学院附属济宁市第一人民医院,山东济宁272000

出　　处：《糖尿病新世界》2015年第8期5-7,共3页Diabetes New World Magazine

摘　　要：目的观察应用二甲双胍(MET)血糖控制不佳的2型糖尿病患者加用西格列汀(SITA)和地特胰岛素(IDet)降糖的有效性及安全性。方法在一个20周开放、随机、平行研究中,服用二甲双胍+磺脲类(SU)的2型糖尿病患者被随机平分到两组,实验组为:IDet+SITA+MET(停用SU),对照组为SITA+MET+SU。观察项目为:糖化血红蛋白、空腹血糖、9点自测血糖、体重、体重指数、腰围、血脂、血压的变化。记录不良事件及低血糖。结果实验组在糖化血红蛋白(HbA1c)、空腹血糖(FPG)、和9点自测血糖(SMPG)明显低于对照组。在实验组中,HbA1c降低1.44%,在对照组中降低0.89%,(P<0.001)。在实验组中,空腹血糖降低3.7 mmol/L(66.3 mg/dL),在对照组中降低1.2 mmol/L(22.2 mg/dL),(P<0.001)。在体重和体重指数中降低无明显差异。两组严重低血糖发生率非常低。结论地特胰岛素联合西格列汀及二甲双胍可以更好的控制血糖,同时低血糖发生率较低,同时无明显增加体重。Objective The aim of this trial is to evaluate the efficacy and safety of the combination of once-daily insulin detemir（IDet） and sitagliptin（SITA） versus SITA ＋ sulphonylurea（SU）, both in combination with metformin （MET） in subjects with type 2 diabetes poorly controlled by MET. Methods In a 20-week, open-label, randomized, parallel-group study in type 2 diabetes, insulin-naive subjects concomitantly treated with MET ＋ sulfonylurea（SU） were randomized 1：1 to two groups, the experimental group and the control group. The experimental group were treated by IDet ＋ SITA ＋ MET, the control group were treated by SITA ＋ MET ＋ SU. All continued with MET treatment, and those treated with SU continued if randomized to SITA ＋ MET ＋ SU. Efficacy endpoints included glycosylated haemoglobin （HbA1c）, fasting plasma glucose （FPG）, 9-point self-measured plasma glucose （SMPG）, weight, body mass index （BMI）, waistline, blood lipid and blood pressure. And the safety endpoints that included adverse events （AEs） and hypoglycaemia were recorded. Results Significantly higher reductions in HbA1c, FPG and SMPG were achieved in the experimental group compared with the control group. The reduction in HbA1c in the experimental group was much greater than that in the control group（1.44% versus 0.89%）（ P〈0.001）. The decrease in FPG in the experimental group was obviously greater than that in the control group[3.7 mmol/L（66.3 mg/dL） versus 1.2 mmol/l （22.2 mg/dL）], P〈0.001. Small decreases in weight and BMI were observed in both groups, with no significant differences. There was no major hypoglycaemia in both groups. Conclusion The combination of IDet with SITA and MET showed a clinically and significantly better improvement in glycaemic control. And it was associated with a low rate of hypoglycaemia and slight weight gain.

关 键 词：2型糖尿病 地特胰岛素 西格列汀 二甲双胍 磺酰脲类 

分 类 号：R587.1[医药卫生—内分泌]