胰岛素degludec, ultra-longacting基础胰岛素,而胰岛素在丹麦basal-bolus进餐时间胰岛素治疗2型糖尿病(开始basal-bolus 2型):一个阶段3,随机、非盲、treat-to-target non-inferiority审判。

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加伯AJ,国王AB,德尔普拉托年代,Sreenan年代,Balci可,Munoz-Torres M, Rosenstock J, Endahl洛杉矶,旧金山,荷兰人P

柳叶刀》。2012年4月21日,379 (9825):1498 - 507。doi: 10.1016 / s0140 - 6736 (12) 60205 - 0。

PubMed ID

22521072 (在PubMed

]

文摘

背景:基础胰岛素治疗并不能阻止β细胞功能丧失,是2型糖尿病的特点,因此糖尿病控制不可避免地恶化。胰岛素degludec是一个新的,ultra-longacting基础胰岛素。我们旨在评估疗效和安全性的胰岛素degludec与2型糖尿病患者的胰岛素。方法:52周,第三阶段,非盲、treat-to-target, non-inferiority试验,进行在12个国家的123个站点,我们参加成年人(年龄> / = 18年)与2型糖尿病和糖化血红蛋白(HbA (1 c)) 7.0 - -10.0%的3个月或更长时间后的胰岛素疗法(有或没有口服抗糖尿病的药物)。我们随机分配资格参与比例3:1获得每日一次皮下胰岛素degludec或甘精,分层前胰岛素疗法,通过一个中央交互反应系统。基础胰岛素滴定目标血浆葡萄糖浓度的3.9 - 5.0 <更易与L self-measured早餐前。主要结果是non-inferiority degludec甘精衡量变化的HbA (1 c)从基线到52周(non-inferiority限制为0.4%)的方差分析全分析集。我们评估在所有治疗患者低血糖的发生率。这项研究是在ClinicalTrials.gov注册,NCT00972283数量。结果:744(99%)的755名参与者随机分配degludec分配的251年和248年(99%)甘精包含在全分析集(平均年龄58.9岁(标准差9.3),糖尿病持续时间13.5年[7.3],[0.8]HbA (1 c) 8.3%,和空腹血糖9.2更易与L [3.1]);618年(82%)和211年(84%)参与者完成了试验。 After 1 year, HbA(1c) decreased by 1.1% in the degludec group and 1.2% in the glargine group (estimated treatment difference [degludec-glargine] 0.08%, 95% CI -0.05 to 0.21), confirming non-inferiority. Rates of overall confirmed hypoglycaemia (plasma glucose <3.1 mmol/L or severe episodes requiring assistance) were lower with degludec than glargine (11.1 vs 13.6 episodes per patient-year of exposure; estimated rate ratio 0.82, 95% CI 0.69 to 0.99; p=0.0359), as were rates of nocturnal confirmed hypoglycaemia (1.4 vs 1.8 episodes per patient-year of exposure; 0.75, 0.58 to 0.99; p=0.0399). Rates of severe hypoglycaemia seemed similar (0.06 vs 0.05 episodes per patient-year of exposure for degludec and glargine) but were too low for assessment of differences. Rates of other adverse events did not differ between groups. INTERPRETATION: A policy of suboptimum diabetes control to reduce the risk of hypoglycaemia and its consequences in advanced type 2 diabetes mellitus might be unwarranted with newer basal insulins such as degludec, which are associated with lower risks of hypoglycaemia than insulin glargine. FUNDING: Novo Nordisk.

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药物: 胰岛素degludec