[The efficacy and safety of insulin degludec versus insulin glargine in insulin-naive subjects with type 2 diabetes: results of a Chinese cohort from a multinational randomized controlled trial].

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 IDeg-IGlar 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.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%CI 0.88～1.82)]。德谷组总体确证低血糖的发生率在数值上低于甘精组，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%CI 0.46～1.03)/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。.