Bays Harold E, Weinstein Richard, Law Gordon, Canovatchel William
Louisville Metabolic and Atherosclerosis Research Center, Louisville, KY, USA.
Obesity (Silver Spring). 2014 Apr;22(4):1042-9. doi: 10.1002/oby.20663. Epub 2013 Dec 9.
To evaluate the effects of canagliflozin, a sodium glucose co-transporter 2 inhibitor, on body weight in overweight and obese subjects (body mass index [BMI] ≥27 and <50 kg/m(2) ).
This 12-week, Phase 2b, randomized, double-blind study enrolled 376 subjects without diabetes mellitus who received canagliflozin 50, 100, or 300 mg or placebo once daily. The primary endpoint was the percent change in body weight from baseline through Week 12.
Canagliflozin increased urinary glucose excretion in a dose-dependent manner and produced statistically significant reductions in body weight compared with placebo (least squares mean percent changes from baseline of -2.2%, -2.9%, -2.7%, and -1.3% with canagliflozin 50, 100, and 300 mg and placebo; P < 0.05 for all comparisons). Overall adverse event (AE) rates were similar across groups. Canagliflozin was associated with higher rates of genital mycotic infections in women, which were generally mild and led to few study discontinuations. Osmotic diuresis-related AE rates were low and similar across groups.
In overweight and obese subjects without diabetes mellitus, canagliflozin significantly reduced body weight compared with placebo and was generally well tolerated.
评估钠-葡萄糖协同转运蛋白2抑制剂卡格列净对超重和肥胖受试者（体重指数[BMI]≥27且<50kg/m²）体重的影响。
这项为期12周的2b期随机双盲研究纳入了376例无糖尿病的受试者，他们每日一次接受50、100或300mg卡格列净或安慰剂治疗。主要终点是从基线至第12周体重的变化百分比。
卡格列净可使尿糖排泄呈剂量依赖性增加，与安慰剂相比，体重有统计学意义的显著降低（卡格列净50、100和300mg组及安慰剂组从基线的最小二乘均值变化百分比分别为-2.2%、-2.9%、-2.7%和-1.3%；所有比较P<0.05）。各组总体不良事件（AE）发生率相似。卡格列净与女性生殖器真菌感染率较高相关，感染通常较轻，导致很少有受试者退出研究。渗透性利尿相关AE发生率较低，且各组相似。
在无糖尿病的超重和肥胖受试者中，与安慰剂相比，卡格列净可显著降低体重，且总体耐受性良好。
