磷酸西他列汀
耐受性
医学
二甲双胍
安慰剂
血压
2型糖尿病
内科学
不利影响
糖尿病
剂量范围研究
临床终点
2型糖尿病
胃肠病学
内分泌学
随机对照试验
双盲
替代医学
病理
作者
Neeta B. Amin,X. Wang,Sunil Jain,D. S. Lee,Gianluca Nucci,James M. Rusnak
摘要
Aim To investigate the efficacy and safety of ertugliflozin, in a phase II dose‐ranging study, in patients with type 2 diabetes mellitus ( T2DM ) inadequately controlled on metformin. Methods A total of 328 patients [mean T2DM duration, 6.3 years; mean glycated haemoglobin ( HbA1c ), 8.1%] were randomized to once‐daily ertugliflozin (1, 5, 10, 25 mg), sitagliptin (100 mg) or placebo, for 12 weeks. The primary efficacy endpoint was change from baseline to week 12 in HbA1c concentration and the secondary efficacy endpoints were changes from baseline to week 12 in body weight, fasting plasma glucose ( FPG ) and systolic/diastolic blood pressure ( SBP / DBP ). Safety and tolerability were also monitored. Results Ertugliflozin (1–25 mg/day) produced significant reductions in HbA1c concentration [placebo‐corrected least‐squares mean ( LSM ) −0.45% (1 mg) to −0.72% (25 mg); p ≤ 0.002, similar to sitagliptin (−0.76%; p = 0.0001)], FPG ( LSM −1.17 to −1.90 mmol/l; p < 0.0001) and body weight (−1.15 to −2.15%; p < 0.0001). The LSM SBP decreased by −3.4 to −4.0 mmHg from baseline with ertugliflozin 5–25 mg/day. No reductions in body weight or blood pressure were observed with sitagliptin. After randomization, 2.7% of patients (9/328) withdrew because of adverse events ( AEs ); the frequency of AEs was evenly distributed across groups. No dose‐related increase in AE frequency occurred with ertugliflozin. Hypoglycaemia was reported in 5 (1.5%) randomized participants (all in the ertugliflozin group). The frequency of urinary tract infection was 3.2% for ertugliflozin (pooled across groups), 1.8% for sitagliptin, 7.4% for placebo, and the frequency of genital fungal infections was 3.7% for ertugliflozin (pooled) versus 1.9% for placebo. Conclusion Ertugliflozin (1–25 mg/day) improved glycaemic control, body weight and blood pressure in patients with T2DM suboptimally controlled on metformin, and was well tolerated.
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