Department of Diabetes, Endocrinology and Nutrition, Instituto de Investigación Biomédica de Málaga (IBIMA) Hospital Universitario Virgen de la Victoria, Universidad Málaga, Málaga, Spain.
CIBER Fisiopatología de la Obesidad y Nutrición (CIBEROBN), Instituto de Salud Carlos III, Málaga, Spain.
Diabetes Obes Metab. 2017 Feb;19(2):266-274. doi: 10.1111/dom.12814. Epub 2016 Nov 24.
AIM: To evaluate the efficacy and safety of linagliptin vs placebo as add-on to empagliflozin and metformin in patients with type 2 diabetes. MATERIALS AND METHODS: Patients with inadequate glycaemic control despite stable-dose metformin received open-label empagliflozin 10 mg (study 1) or 25 mg (study 2) as add-on therapy for 16 weeks. Subsequently, those with HbA1c ≥7.0 and ≤10.5% (>53 and ≤91 mmol/mol) (N = 482) were randomized to 24 weeks' double-blind, double-dummy treatment with linagliptin 5 mg or placebo in study 1, or to linagliptin 5 mg or placebo in study 2; all patients continued treatment with metformin and empagliflozin 10 mg (study 1) or metformin and empagliflozin 25 mg (study 2). The primary endpoint was change from baseline (defined as the last value before first intake of randomized, double-blind treatment) in HbA1c at week 24. RESULTS: At week 24, HbA1c (mean baseline 7.82-8.04 [62-64 mmol/mol]) was significantly reduced with linagliptin vs placebo; adjusted mean (SE) differences in change from baseline in HbA1c with linagliptin vs placebo were -.32% (.10) (-3.59 [1.08] mmol/mol) ( P = .001) for patients on empagliflozin 10 mg and metformin, and -0.47% (0.10) (-5.15 [1.04] mmol/mol) ( P < 0.001) for patients on empagliflozin 25 mg and metformin. Adverse events were reported in more patients receiving placebo than in those receiving linagliptin: 55.5% vs 48.4% in study 1 and 58.9% vs 52.7% in study 2. CONCLUSIONS: Linagliptin as add-on to empagliflozin and metformin for 24 weeks improved glycaemic control vs placebo, and was well tolerated.
目的：评估利拉利汀作为附加疗法与安慰剂相比，在二甲双胍和恩格列净治疗控制不佳的 2 型糖尿病患者中的疗效和安全性。
材料和方法：尽管接受了稳定剂量的二甲双胍治疗，但血糖控制仍不理想的患者接受了为期 16 周的开放标签恩格列净 10 mg（研究 1）或 25 mg（研究 2）的附加治疗。随后，将 HbA1c≥7.0 且≤10.5%（>53 且≤91mmol/mol）（N=482）的患者随机分为两组，分别接受为期 24 周的利拉利汀 5mg 或安慰剂的双盲、双模拟治疗（研究 1），或接受利拉利汀 5mg 或安慰剂的治疗（研究 2）；所有患者继续接受二甲双胍和恩格列净 10mg（研究 1）或二甲双胍和恩格列净 25mg（研究 2）治疗。主要终点为第 24 周时与基线相比的 HbA1c 变化（定义为首次接受随机、双盲治疗前的最后一次值）。
结果：第 24 周时，与安慰剂相比，利拉利汀显著降低了 HbA1c（平均基线值为 7.82-8.04[62-64mmol/mol]）；利拉利汀与安慰剂相比，HbA1c 从基线的变化的调整平均（SE）差异为-0.32%（0.10）（-3.59[1.08]mmol/mol）（P=0.001），在接受恩格列净 10mg 和二甲双胍的患者中；在接受恩格列净 25mg 和二甲双胍的患者中，差异为-0.47%（0.10）（-5.15[1.04]mmol/mol）（P<0.001）。接受安慰剂的患者比接受利拉利汀的患者报告的不良事件更多：研究 1 中为 55.5%比 48.4%，研究 2 中为 58.9%比 52.7%。
结论：利拉利汀作为恩格列净和二甲双胍的附加疗法治疗 24 周可改善血糖控制，优于安慰剂，且耐受性良好。
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