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Efficacy and safety of triple therapy with dapagliflozin add-on to saxagliptin plus metformin over 52 weeks in patients with type 2 diabetes

机译:沙格列汀联合二甲双胍联合达格列净联合三联疗法在2型糖尿病患者中的疗效和安全性超过52周

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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.
机译:我们先前曾报道,对于2型糖尿病患者,治疗24周后,沙格列汀加二甲双胍与dapagliflozin相比于安慰剂可导致糖化血红蛋白(A1C),空腹血糖(FPG)和体重(BW)的更大降低( T2D)。在这里,我们报告治疗52周后的结果。服用开放性二甲双胍和沙格列汀5 mg /天稳定8-16周的患者被随机分组​​接受安慰剂或dapagliflozin 10 mg /天加开放性沙克列汀+二甲双胍52周。在A1C(-0.74%vs. 0.07%),FPG(-27 vs. 10 mg / dL)和BW(-2.1 vs. -0.4 kg)中,达格列净与安慰剂相比,从基线到第52周的变化更大。与安慰剂(12.6%)相比,更多的达格列净(29.4%)患者达到A1C <7%。达格列净(66%)和安慰剂(71%)的不良事件相似,低血糖症很少见(<= 2%)。达格列净(6%)比安慰剂(1%)多发生于生殖器感染。两组之间的尿路感染发生率相似(9%vs. 10%)。沙格列汀加二甲双胍联合达格列净添加三联疗法是治疗T2D的持久,有效且耐受良好的干预措施。

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