Hartley Paul, Shentu Yue, Betz-Schiff Patricia, Golm Gregory T, Sisk Christine McCrary, Engel Samuel S, Shankar R Ravi
Preferred Primary Care Physicians, Uniontown, PA, USA.
Drugs Aging. 2015 Jun;32(6):469-76. doi: 10.1007/s40266-015-0271-z.
The aim of this study was to evaluate the efficacy and tolerability of sitagliptin compared with glimepiride in elderly patients with type 2 diabetes mellitus (T2DM) and inadequate glycemic control with diet and exercise alone.
This was a randomized, parallel-group, multinational, non-inferiority clinical trial with an active-controlled, double-blind treatment period in which patients ≥ 65 and ≤ 85 years of age with T2DM were screened at 85 sites. Patients were randomized to once-daily sitagliptin (100 or 50 mg, depending on renal function) or glimepiride (in titrated doses) for 30 weeks. The main outcome measures were change from baseline in glycated hemoglobin (HbA1c), fasting plasma glucose (FPG), and body weight; and the incidence of symptomatic hypoglycemia.
The mean baseline HbA1c was 7.8% in both the sitagliptin group (n = 197) and the glimepiride group (n = 191). After 30 weeks, the least squares (LS) mean change in HbA1c baseline was -0.32% with sitagliptin and -0.51 % with glimepiride, for a between-group difference (95% CI) of 0.19% (0.03-0.34). This result met the pre-specified criterion for declaring non-inferiority, which required that the upper 95% confidence limit lie below 0.4%. The LS mean change in FPG from baseline was -14.5 mg/dL with sitagliptin and -21.2 mg/dL with glimepiride, for a between-group difference (95% CI) of 6.7 mg/dL (0.7-12.7). The percentages of patients with adverse events of symptomatic hypoglycemia were 0.8% in the sitagliptin group and 4.7% in the glimepiride group (between-treatment difference = -3.9%, p = 0.009). The LS mean change in body weight from baseline was 0.4 kg with sitagliptin and 1.1 kg with glimepiride, for a between-group difference of -0.7 kg (p = 0.011).
In elderly patients with T2DM and inadequate glycemic control with diet and exercise alone, sitagliptin provided non-inferior glycemic control after 30 weeks of treatment compared with glimepiride. Compared with glimepiride, sitagliptin had a lower risk of hypoglycemia. Sitagliptin was weight-neutral; while the between-group difference in change from baseline in body weight was statistically significant, the modest difference may not be clinically meaningful.
ClinicalTrials.gov NCT01189890.
本研究旨在评估与格列美脲相比，西格列汀在老年2型糖尿病（T2DM）患者中，以及在仅通过饮食和运动血糖控制不佳时的疗效和耐受性。
这是一项随机、平行组、多国、非劣效性临床试验，有一个活性药物对照的双盲治疗期，在85个地点对年龄≥65岁且≤85岁的T2DM患者进行筛查。患者被随机分配接受每日一次的西格列汀（100或50mg，取决于肾功能）或格列美脲（滴定剂量）治疗30周。主要结局指标为糖化血红蛋白（HbA1c）、空腹血糖（FPG）和体重相对于基线的变化；以及症状性低血糖的发生率。
西格列汀组（n = 197）和格列美脲组（n = 191）的平均基线HbA1c均为7.8%。30周后，西格列汀组HbA1c基线的最小二乘（LS）平均变化为-0.32%，格列美脲组为-0.51%，组间差异（95%CI）为0.19%（0.03 - 0.34）。该结果符合预先设定的非劣效性标准，即95%置信上限需低于0.4%。FPG相对于基线的LS平均变化，西格列汀组为-14.5mg/dL，格列美脲组为-21.2mg/dL，组间差异（95%CI）为6.7mg/dL（0.7 - 12.7）。症状性低血糖不良事件患者的百分比，西格列汀组为0.8%，格列美脲组为4.7%（治疗组间差异 = -3.9%，p = 0.009）。体重相对于基线的LS平均变化，西格列汀组为0.4kg，格列美脲组为1.1kg，组间差异为-0.7kg（p = 0.011）。
在老年T2DM患者中，以及在仅通过饮食和运动血糖控制不佳时，西格列汀治疗30周后的血糖控制效果与格列美脲相比不劣。与格列美脲相比，西格列汀发生低血糖的风险更低。西格列汀对体重无影响；虽然体重相对于基线变化的组间差异具有统计学意义，但这种微小差异可能无临床意义。
ClinicalTrials.gov NCT01189890。
