摘要
目的 比较德谷胰岛素与甘精胰岛素的疗效和安全性.方法 为期26周、随机、开放标签、平行分组、治疗达标试验,中国亚组共纳入了560例口服药控制不佳的2型糖尿病患者（平均年龄56岁,平均病程7年）.受试者以2∶1比例随机接受德谷胰岛素（德谷组,373例）或甘精胰岛素（甘精组,187例）治疗,均联合应用二甲双胍.主要终点指标为治疗26周后糖化血红蛋白（HbA1c）相对于基线的改变.结果 平均HbA1c分别从8.2％下降到6.9％（德谷组）和8.2％下降到7.0％（甘精组）.治疗差异（德谷组-甘精组）为-0.10％（95％CI-0.24 ～0.05）.德谷组和甘精组HbA1c ＜7.0％达标的受试者百分比分别为56.3％和49.7％[比值比1.26（95％ CI0.88～ 1.82）].德谷组总体确证低血糖的发生率在数值上低予甘精组,确证的夜间低血糖显著低于甘精组、具有统计学意义[发生率的比值分别为0.69（95％ CI0.46～ 1.03）/0.43（95％ CI 0.19 ～0.97）].其他安全性指标组间差异无统计学意义.结论 德谷胰岛素治疗具有良好的血糖控制,非劣于甘精胰岛素;并且,其夜间确证低血糖的发生率显著低于甘精胰岛素.对于口服药控制不佳需起始基础胰岛素治疗的中国2型糖尿病患者,德谷胰岛素是一种合适的选择.临床试验注册美国临床试验数据库,NCT01849289.
Objective To compare the safety and efficacy of insulin degludec （IDeg） with those of insulin glargine （IGlar） in insulin-naive subjects with type 2 diabetes （T2DM）.Methods This was a 26-week,randomized,open-label,parallel-group,treat-to-target trial in 560 Chinese subjects with T2DM （men/women：274/263,mean age 56 years,mean diabetes duration 7 years） inadequately controlled on oral antidiabetic drugs （OADs）.Subjects were randomized 2：1 to once-daily IDeg （373 subjects） or IGlar（187 subjects）,both in combination with metformin.The primary endpoint was changes from baseline in glycosylated hemoglobin（HbA1c） after 26 weeks.Results Mean HbA1c decreased from 8.2% in both groups to 6.9% in IDeg and 7.0% in IGlar,respectively.Estimated treatment difference （ETD） of IDegIGlar in change from baseline was-0.10% points （95% CI-0.25-0.05）.The proportion of subjects achieving HbA1c 〈 7.0% was 56.3% and 49.7% with IDeg and IGlar,respectively [estimated odds ratio of IDeg/IGlar：1.26 （95 % CI 0.88-1.82）].Numerically lower rateof overall confirmed hypoglycaemia and statistically significantly lower nocturnal confirmed hypoglycemia were associated with IDeg compared with IGlar,respectively [estimated rateratio of IDeg/IGlar 0.69 （95% CI 0.46-1.03）,and 0.43 （95% CI 0.19-0.97）].No differences in other safety parameters were found between the two groups.Conclusions IDeg was non-inferior to IGlar in terms of glycaemic control,and was associated with a statistically significantly lower rate of nocturnal confirmed hypoglycaemia.IDeg is considered to be suitable for initiating insulin therapy in Chinese T2DM patients on OADs requiring intensified treatment.Clinical trail registration Clinicaltrials.gov,NCT01849289.
出处
《中华内科杂志》
CAS
CSCD
北大核心
2017年第9期660-666,共7页
Chinese Journal of Internal Medicine
