Clinical and Experimental Endocrinology, Katholieke Universiteit Leuven, Leuven, Belgium.
Servicio of Endocrinologia, Torre Medica, Guadalajara, Mexico.
Diabetes Obes Metab. 2016 Nov;18(11):1134-1137. doi: 10.1111/dom.12737. Epub 2016 Aug 19.
We previously reported that dapagliflozin versus placebo as add-on to saxagliptin plus metformin resulted in greater reductions in glycated haemoglobin (A1C), fasting plasma glucose (FPG) and body weight (BW) after 24 weeks of treatment in patients with type 2 diabetes (T2D). Here we report results after 52 weeks of treatment. Patients stabilized on open-label metformin and saxagliptin 5 mg/day for 8-16 weeks were randomized to placebo or dapagliflozin 10 mg/day plus open-label saxagliptin plus metformin for 52 weeks. Changes from baseline to week 52 were greater with dapagliflozin versus placebo in A1C (-0.74% vs. 0.07%), FPG (-27 vs. 10 mg/dL) and BW (-2.1 vs. -0.4 kg). More patients achieved A1C <7% with dapagliflozin (29.4%) versus placebo (12.6%). Adverse events were similar with dapagliflozin (66%) and placebo (71%), and hypoglycaemia was rare (≤2%). Genital infections occurred more often with dapagliflozin (6%) than with placebo (1%); frequency of urinary tract infections was similar between the two groups (9% vs. 10%). Triple therapy with dapagliflozin add-on to saxagliptin plus metformin is a durable, effective and well-tolerated intervention for the treatment of T2D.
我们之前报道过，在接受 24 周治疗后，与安慰剂相比，达格列净联合沙格列汀和二甲双胍可使 2 型糖尿病（T2D）患者的糖化血红蛋白（A1C）、空腹血糖（FPG）和体重（BW）进一步降低。在此，我们报告 52 周治疗后的结果。在 8-16 周内接受开放标签的二甲双胍和沙格列汀 5mg/天治疗稳定的患者，随机分为安慰剂组或达格列净 10mg/天联合开放标签的沙格列汀和二甲双胍组，治疗 52 周。与安慰剂相比，达格列净治疗后 A1C（-0.74%对 0.07%）、FPG（-27 对 10mg/dL）和 BW（-2.1 对-0.4kg）的降低更为显著。更多的患者使用达格列净（29.4%）实现了 A1C<7%，而安慰剂组为 12.6%。达格列净（66%）和安慰剂（71%）的不良反应相似，且低血糖很少见（≤2%）。与安慰剂组（1%）相比，达格列净组生殖道感染更为常见（6%）；两组尿路感染的发生率相似（9%对 10%）。达格列净联合沙格列汀和二甲双胍的三联疗法是治疗 T2D 的一种持久、有效且耐受良好的干预措施。
