摘要
目的针对二甲双胍治疗血糖控制不佳的中国2型糖尿病患者,评估司美格鲁肽片对比西格列汀治疗的有效性与安全性。方法PIONEER12研究是一项Ⅲ期临床研究。预设中国亚组人群随机分配至司美格鲁肽片3 mg、7 mg和14 mg组或西格列汀100 mg组。主要终点为第26周时HbA 1C较基线的变化,确证性次要有效性终点为第26周时体重较基线的变化。结果共纳入1084例中国受试者。基线时,平均年龄约为53岁,男性占比62.2%,糖尿病病程5.5年,HbA 1C为8.2%,体重为74.3 kg。经过26周治疗,司美格鲁肽片3 mg、7 mg和14 mg组HbA 1C分别下降0.9%、1.4%和1.6%,西格列汀100 mg组HbA 1C下降0.7%。各组与西格列汀组的估计治疗差异分别为-0.2%(95%CI-0.4~-0.0)、-0.8%(95%CI-0.9~-0.6)和-0.9%(95%CI-1.1~-0.8),差异均具统计学意义(3 mg组,P=0.011;7 mg和14 mg组,P<0.001)。司美格鲁肽片各组体重相对基线的改变分别为-1.1 kg、-2.5 kg和-3.4 kg,西格列汀组为-0.4 kg,各组与西格列汀组的估计治疗差异分别为-0.8 kg(95%CI-1.3~-0.2)、-2.1 kg(95%CI-2.6~-1.6)和-3.0 kg(95%CI-3.5~-2.5;3 mg组,P=0.004;7 mg和14 mg组,P<0.001)。所有治疗组不良事件发生率相当,主要不良反应为胃肠道反应,大部分为轻、中度,且呈一过性。结论对于二甲双胍治疗血糖控制不佳的中国2型糖尿病患者,所有剂量的司美格鲁肽片治疗26周降糖和减重效果均优于西格列汀100 mg,且安全性和耐受性良好。
ObjectiveTo evaluate the efficacy and safety of oral semaglutide versus sitagliptin in Chinese patients with type 2 diabetes mellitus(T2DM)inadequately controlled with metformin.MethodsThe PIONEER 12 study was a phaseⅢclinical trial.Chinese patients were prospectively randomized to oral semaglutide(3mg,7 mg,and 14 mg)or sitagliptin 100 mg.The primary endpoint was the change in HbA 1C from baseline to week 26,and the confirmatory secondary efficacy endpoint was the change in body weight from baseline to week 26.ResultsTotally 1084 Chinese participants(mean age 53 years,male 62.2%,mean duration of diabetes 5.5 years,HbA 1C 8.2%,and body weight 74.3 kg)were enrolled.The changes in HbA 1C at week 26 from baseline were-0.9%,-1.4%,and-1.6%for oral semaglutide 3 mg,7 mg,and 14 mg,respectively,and-0.7%for sitagliptin.Compared to sitagliptin,oral semaglutide 3 mg,7 mg,and 14 mg significantly reduced HbA 1C[estimated treatment difference(ETD),-0.2%(95%CI-0.4--0.0),-0.8%(95%CI-0.9--0.6),and-0.9%(95%CI-1.1--0.8),respectively;3 mg,P=0.011,7 mg and 14mg,P<0.001].The estimated mean changes in body weight at week 26 from baseline were-1.1 kg,-2.5 kg,and-3.4 kg for oral semaglutide 3 mg,7 mg,and 14 mg,respectively,and-0.4 kg for sitagliptin 100 mg.Compared with sitagliptin,oral semaglutide 3 mg,7 mg,and 14 mg significantly reduced body weight[ETD,-0.8 kg(95%CI-1.3--0.2),-2.1 kg(95%CI-2.6--1.6),and-3.0 kg(95%CI-3.5--2.5),respectively;3 mg,P=0.004,7 mg and 14 mg,P<0.001].The overall incidence of adverse events was similar across all treatment groups.The most common adverse events were gastrointestinal disorders,mostly mild or moderate in severity and transient in duration.ConclusionsOral semaglutide resulted in significantly greater reduction in HbA 1C and body weight versus sitagliptin at week 26,with a favorable safety and tolerability profile in Chinese T2DM patients inadequately controlled with metformin.
作者
纪立农
胡吉
蒋晓真
刘军
刘纹琰
孟琦
申泽薇
Ji Linong;Hu Ji;Jiang Xiaozhen;Liu Jun;Liu Wenyan;Meng Qi;Shen Zewei(Department of Endocrinology,Peking University,People′s Hospital,Beijing 100044,China;Department of Endocrinology,the Second Affiliated Hospital of Soochow University,Suzhou 215004,China;Department of Endocrinology,Shanghai Pudong New Area People′s Hospital,Shanghai 201200,China;Department of Endocrinology,Shanghai Fifth People′s Hospital,Fudan University,Shanghai 200240,China;Medical Quality,Novo Nordisk(Shanghai)Pharmaceutical Trading Co.,Ltd.,Beijing 100102,China)
出处
《中华内分泌代谢杂志》
CAS
CSCD
北大核心
2024年第10期835-843,共9页
Chinese Journal of Endocrinology and Metabolism
