西格列汀对比阿卡波糖在中国经二甲双胍单药治疗血糖控制不佳的 2 型糖尿病患者中的疗效和安全性：一项 IV 期开放标签随机对照研究（SMART 研究）的结果。
Efficacy and safety of saxagliptin compared with acarbose in Chinese patients with type 2 diabetes mellitus uncontrolled on metformin monotherapy: Results of a Phase IV open-label randomized controlled study (the SMART study).
机构信息
Department of Endocrinology, Chinese People's Liberation Army General Hospital, Beijing, People's Republic of China.
Department of Endocrinology, the People's Hospital of Liaoning Province, Shenyang, People's Republic of China.
出版信息
Diabetes Obes Metab. 2017 Nov;19(11):1513-1520. doi: 10.1111/dom.12942. Epub 2017 Jul 6.
AIM
To investigate the efficacy, safety and tolerability of saxagliptin compared with acarbose in Chinese patients with type 2 diabetes mellitus inadequately controlled with metformin monotherapy.
METHODS
SMART was a 24-week, multicentre, randomized, parallel-group, open-label Phase IV study conducted at 35 sites in China (September 24, 2014 to September 29, 2015). The primary outcome was absolute change from baseline in HbA1c at Week 24. Secondary outcomes assessed at Week 24 included the proportion of patients achieving HbA1c < 7.0%, the proportion of patients with gastrointestinal adverse events (GI AEs), and the proportion of patients achieving HbA1c < 7.0% without GI AEs. Safety and tolerability were also assessed in all patients who received ≥1 dose of study medication.
RESULTS
Four-hundred and eighty-eight patients were randomized (1:1) to saxagliptin or acarbose via a central randomization system (interactive voice/web response system); 241 and 244 patients received saxagliptin and acarbose, respectively, and 238 and 243 of these had ≥1 pre- and ≥1 post-baseline efficacy values recorded. Saxagliptin was non-inferior to acarbose for glycaemic control [Week 24 HbA1c change: -0.82% and -0.78%, respectively; difference (95% confidence interval): -0.04 (-0.22, 0.13)%], with similar proportions of patients in both treatment groups achieving HbA1c < 7.0%. However, fewer GI AEs were reported with saxagliptin compared with acarbose, and a greater number of patients who received saxagliptin achieved HbA1c < 7.0% without GI AEs compared with those receiving acarbose.
CONCLUSION
Both therapies had similar efficacy profiles. However, saxagliptin was associated with fewer GI AEs, suggesting it might be preferential for clinical practice.
CLINICAL TRIAL REGISTRATION NUMBER
NCT02243176, clinicaltrials.gov.
目的
研究西格列汀对比阿卡波糖在二甲双胍单药治疗控制不佳的中国 2 型糖尿病患者中的疗效、安全性和耐受性。
方法
SMART 是一项在中国 35 个中心进行的为期 24 周、多中心、随机、平行分组、开放性、IV 期研究（2014 年 9 月 24 日至 2015 年 9 月 29 日）。主要终点为 24 周时 HbA1c 与基线相比的绝对变化。24 周时评估的次要终点包括达到 HbA1c＜7.0%的患者比例、发生胃肠道不良事件（GI AE）的患者比例，以及未发生 GI AE 时达到 HbA1c＜7.0%的患者比例。所有接受至少 1 次研究药物治疗的患者也进行了安全性和耐受性评估。
结果
488 例患者通过中央随机系统（交互式语音/网络应答系统）按 1:1 随机分为西格列汀或阿卡波糖组；241 例和 244 例患者分别接受了西格列汀和阿卡波糖治疗，其中 238 例和 243 例患者分别有≥1 次基线前和≥1 次基线后疗效值记录。24 周时，西格列汀的血糖控制不劣于阿卡波糖[HbA1c 变化：分别为-0.82%和-0.78%；差值（95%置信区间）：-0.04（-0.22，0.13）%]，两组达到 HbA1c＜7.0%的患者比例相似。然而，与阿卡波糖相比，西格列汀报告的胃肠道不良事件更少，接受西格列汀治疗的患者中，达到 HbA1c＜7.0%且无胃肠道不良事件的患者比例大于接受阿卡波糖治疗的患者。
结论
两种治疗方法的疗效相似。然而，西格列汀与较少的胃肠道不良事件相关，这表明它在临床实践中可能更具优势。
临床试验注册编号
NCT02243176，clinicaltrials.gov。
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