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首页> 外文期刊>Diabetes, obesity & metabolism >Sustained 52‐week efficacy and safety of triple therapy with dapagliflozin plus saxagliptin versus dual therapy with sitagliptin added to metformin in patients with uncontrolled type 2 diabetes
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Sustained 52‐week efficacy and safety of triple therapy with dapagliflozin plus saxagliptin versus dual therapy with sitagliptin added to metformin in patients with uncontrolled type 2 diabetes

机译：用Dapagliflozin加saxagliptin与Saxagliptin与SitaGliptin的双重治疗持续52周的疗效和安全性，在不受控制的2型糖尿病患者中添加到二甲双胍中

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Aims To compare the efficacy and safety of an intensification strategy of early triple combination therapy with dapagliflozin (DAPA) plus saxagliptin (SAXA) to a dual therapy strategy with sitagliptin (SITA) in patients with type 2 diabetes who are inadequately controlled with metformin (MET) monotherapy. Materials and methods This multinational, active‐controlled, parallel‐group phase 3b trial randomized 461 patients, at least 18?years of age, with glycated haemoglobin (HbA1c) of 8%–10.5% (64–91?mmol/mol), to either DAPA plus SAXA or SITA, added to MET, for a 26‐week double‐blind treatment period and an extension of a 26‐week blinded treatment period. Results Mean (± SD) baseline HbA1c was 8.8%?± 0.9% (73.0 ± 9.3 mmol/mol). DAPA plus SAXA ( n =?232) provided a greater reduction from baseline in HbA1c at Weeks 26 and 52 compared with SITA ( n =?229) (adjusted mean?±?SE change, Week 26: ?1.41?± 0.07% vs ?1.07?± 0.07% [?15.4 ± 0.8 mmol/mol vs 11.7 ± 0.8 mmol/mol]; P = 0.0008; Week 52: ?1.29?± 0.08% vs ?0.81?± 0.09% [14.1 ± 0.9 mmol/mol vs 8.9 ± 1.0 mmol/mol]). The between‐group difference in adjusted mean (95% CI) change from baseline in HbA1c increased from ?0.34 (?0.54, ?0.14) at Week 26 to ?0.48 (?0.71, ?0.25) at Week 52. DAPA plus SAXA was generally well tolerated and the incidence of adverse events was similar in both treatment arms. Conclusions Early intensification to triple therapy with DAPA plus SAXA results in better, more durable glycaemic control than addition of SITA only (dual therapy) in patients with high HbA1c levels who are uncontrolled with MET monotherapy.
机译：旨在比较早期三重组合治疗的强化策略与Dapagliflozin（DAPA）加上Saxagliptin（SAXA）与SitaGliptin（SITA）的患者与二甲双胍不充分控制的患者的双重治疗策略（满足）单疗法。材料和方法本跨国，主动控制，并联阶段3B试验随机化461名患者，至少18岁，血糖血红蛋白（HBA1C）为8％-10.5％（64-91摩尔/摩尔），对于DAPA加SAXA或SITA，添加到满足，为26周的双盲治疗期和延长26周的蒙蔽治疗期。结果平均值（±SD）基线HBA1C为8.8％？±0.9％（73.0±9.3mmol / mol）。 DAPA加SAXA（n =Δ232）在与SITA（n =Δ229）相比，在HBA1c中的基线中的基线更大减少（调整平均值？±α？SE变化，第26周：？1.41？±0.07％VS ？1.07？±0.07％[±0.8mmol / mol vs 11.7±0.8 mmol / mol]; p = 0.0008;第52周：？1.29？±0.08％Vs？0.81？±0.09％[14.1±0.9 mmol / mol与8.9±1.0 mmol / mol]）。在第26周，HBA1C中的调整平均值（95％CI）的组差异从HBA1c中的基线变化增加到0.34（？0.54，Δ0.14），在第52周的时间为0.48（？0.71，？0.25）.DAPA加SAXA是在两种治疗臂中，通常耐受良好的耐受性和不良事件的发生率类似。结论与DAPA加SAXA对三重治疗的早期增强导致比患有Met Monotherapy不受控制的高HBA1C水平的SITA（双重治疗）更好，更耐用的血糖控制。

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