Voglibose for prevention of type 2 diabetes mellitus: a randomised, double-blind trial in Japanese individuals with impaired glucose tolerance
Voglibose for prevention of type 2 diabetes mellitus: a randomised, double-blind trial in Japanese individuals with impaired glucose tolerance
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DOI：
10.1016/s0140-6736(09)60222-1
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发表时间：
2009-05-09
期刊：
影响因子：
168.9
通讯作者：
Koku, Kohei
中科院分区：
文献类型：
--
作者：
Kawamori, Ryuzo;Tajima, Naoko;Koku, Kohei
背景2型糖尿病患病率的增加是健康提供者的主要关注点。因此，我们评估伏格列波糖，一种α-葡萄糖苷酶抑制剂，是否可以预防高风险的日本糖耐量受损个体发生2型糖尿病。方法1780例符合条件的患者，标准饮食和定期运动，糖耐量受损，随机分为口服伏格列波糖0.2 mg，每日3次（n=897）或安慰剂（n=883），双盲平行组试验。治疗持续至受试者发生2型糖尿病（主要终点）或正常血糖（次要终点），或至少3年，取决于中期分析的结果。通过全分析集进行分析。该试验在大学医院医学信息网络（UMIN）临床试验登记处注册，编号UMIN 000001109。结果在中期分析中，伏格列波糖治疗平均48.1周（SD 36.3）的个体优于安慰剂（p=0.0026）。伏格列波糖治疗的患者进展为2型糖尿病的风险低于安慰剂治疗的患者（897例中50例vs 881例中106例;风险比0.595，95%CI 0.433-0.818; p=0.0014）。伏格列波糖组达到正常血糖的人数多于安慰剂组（897人中599人vs 881人中454人; 1.539，1.357-1.746; p
Background The increased prevalence of type 2 diabetes mellitus is a major concern for health providers. We therefore assessed whether voglibose, an a-glucosidase inhibitor, could prevent the development of type 2 diabetes in high-risk Japanese individuals with impaired glucose tolerance.Methods 1780 eligible patients on a standard diet and taking regular exercise with impaired glucose tolerance were randomly assigned to oral voglibose 0.2 mg three times a day (n=897) or placebo (n=883) in a multicentre, double-blind, parallel group trial. Treatment was continued until participants developed type 2 diabetes (primary endpoint) or normoglycaemia (secondary endpoint), or for a minimum of 3 years, subject to the findings of an interim analysis. Analysis was by full analysis set. This trial is registered with the University Hospital Medical Information Network (UMIN) clinical trials registry, number UMIN 000001109.Findings In the interim analysis, voglibose was better than placebo (p=0.0026) in individuals treated for an average of 48.1 weeks (S D 36.3). Patients treated with voglibose had a lower risk of progression to type 2 diabetes than did those on placebo (50 of 897 vs 106 of 881; hazard ratio 0.595, 95% CI 0.433-0.818; p=0.0014). More people in the voglibose group achieved normoglycaemia than did those in the placebo group (599 of 897 vs 454 of 881; 1.539, 1.357-1.746; p