Kim Sang Soo, Kim In Joo, Lee Kwang Jae, Park Jeong Hyun, Kim Young Il, Lee Young Sil, Chung Sung Chang, Lee Sang Jin
Division of Endocrinology and Metabolism, Department of Internal Medicine, Pusan National University Hospital, Busan, South Korea.
Biomedical Research Institute, Pusan National University Hospital, Busan, South Korea.
J Diabetes. 2017 Apr;9(4):412-422. doi: 10.1111/1753-0407.12432. Epub 2016 Aug 8.
Early initiation of combination therapy using antihyperglycemic agents is recommended for treating type 2 diabetes (T2D). The present multicenter double-blind randomized parallel-group study examined the efficacy and safety of a sitagliptin and metformin fixed-dose combination (Sita/Met) compared with glimepiride in T2D patients as initial treatment.
Type 2 diabetes patients (aged ≥18 years) were randomized to Sita/Met or glimepiride for 30 weeks after a wash-off run-in period. The primary endpoint was change from baseline (CFB) in HbA1c. Secondary endpoints included the proportion of patients achieving target goal (HbA1c < 7.0 % [53 mmol/mol]) and CFB in fasting plasma glucose (FPG). Safety assessments comprised weight gain from baseline and the incidence of adverse events (AEs).
In total, 292 patients were randomized to Sita/Met (n = 147) or glimepiride (n = 145). After 30 weeks, Sita/Met demonstrated superiority over glimepiride in reducing HbA1c (-1.49 % vs -0.71 %, respectively; between-group difference - 0.78 %; P < 0.001). A significantly higher proportion of patients achieved the target goal with Sita/Met (81.2 %) than with glimepiride (40.1 %; P < 0.001). Greater reduction in FPG occurred with Sita/Met than with glimepiride (least-squares mean difference - 23.5 mg/dL; P < 0.001). Both drugs were generally well tolerated. Hypoglycemia events and weight gain were significantly lower in patients with Sita/Met than with glimepiride (5.5 % vs 20.1 % and -0.83 vs +0.90 kg, respectively; both P < 0.001). No serious drug-related AEs or deaths were reported.
Compared with glimepiride, Sita/Met as an initial treatment led to significantly greater improvements in glycemic control and body weight changes, with a lower incidence of hypoglycemia, over 30 weeks.
推荐早期使用抗高血糖药物联合治疗2型糖尿病（T2D）。本多中心双盲随机平行组研究比较了西他列汀与二甲双胍固定剂量复方制剂（西他列汀/二甲双胍）和格列美脲作为初始治疗对T2D患者的疗效和安全性。
2型糖尿病患者（年龄≥18岁）在洗脱导入期后随机分为西他列汀/二甲双胍组或格列美脲组，治疗30周。主要终点是糖化血红蛋白（HbA1c）较基线的变化（CFB）。次要终点包括达到目标值（HbA1c<7.0%[53 mmol/mol]）的患者比例以及空腹血糖（FPG）的CFB。安全性评估包括基线体重增加和不良事件（AE）的发生率。
总共292例患者被随机分为西他列汀/二甲双胍组（n = 147）或格列美脲组（n = 145）。30周后，西他列汀/二甲双胍在降低HbA1c方面优于格列美脲（分别为-1.49%和-0.71%；组间差异-0.78%；P<0.001）。达到目标值的患者比例西他列汀/二甲双胍组（81.2%）显著高于格列美脲组（40.1%；P<0.001）。西他列汀/二甲双胍组FPG的降低幅度大于格列美脲组（最小二乘均值差异-23.5 mg/dL；P<0.001）。两种药物总体耐受性良好。西他列汀/二甲双胍组患者的低血糖事件和体重增加显著低于格列美脲组（分别为5.5%对20.1%和-0.83对+0.90 kg；均P<0.001）。未报告严重的药物相关不良事件或死亡。
与格列美脲相比，西他列汀/二甲双胍作为初始治疗在30周内可显著改善血糖控制和体重变化，低血糖发生率更低。
