University of Texas Health Science Center, San Antonio, TX
National Research Institute, Los Angeles, CA.
Diabetes Care. 2015 Mar;38(3):384-93. doi: 10.2337/dc14-2364. Epub 2015 Jan 12.
To evaluate the efficacy and safety of combinations of empagliflozin/linagliptin as second-line therapy in subjects with type 2 diabetes inadequately controlled on metformin.
Subjects were randomized to a combination of empagliflozin 25 mg/linagliptin 5 mg (n = 137), empagliflozin 10 mg/linagliptin 5 mg (n = 136), empagliflozin 25 mg (n = 141), empagliflozin 10 mg (n = 140), or linagliptin 5 mg (n = 132) as add-on to metformin for 52 weeks. The primary end point was change from baseline in HbA1c at week 24.
At week 24, reductions in HbA1c (mean baseline 7.90-8.02% [62.8-64.1 mmol/mol]) with empagliflozin/linagliptin were superior to those with empagliflozin or linagliptin alone as add-on to metformin; adjusted mean (SE) changes from baseline were -1.19% (0.06) (-13.1 mmol/mol [0.7]) with empagliflozin 25 mg/linagliptin 5 mg, -1.08% (0.06) (-11.8 mmol/mol [0.7]) with empagliflozin 10 mg/linagliptin 5 mg, -0.62% (0.06) (-6.8 mmol/mol [0.7]) with empagliflozin 25 mg, -0.66% (0.06) (-7.2 mmol/mol [0.7]) with empagliflozin 10 mg, and -0.70% (0.06) (-7.6 mmol/mol [0.7]) with linagliptin 5 mg (P < 0.001 for all comparisons). In these groups, respectively, 61.8, 57.8, 32.6, 28.0, and 36.1% of subjects with baseline HbA1c ≥7% (≥53 mmol/mol) had HbA1c <7% (<53 mmol/mol) at week 24. Efficacy was maintained at week 52. The proportion of subjects with adverse events (AEs) over 52 weeks was similar across treatment arms (68.6-73.0%), with no hypoglycemic AEs requiring assistance.
Combinations of empagliflozin/linagliptin as second-line therapy for 52 weeks significantly reduced HbA1c compared with the individual components and were well tolerated.
评估恩格列净/利拉利汀联合治疗作为二甲双胍控制不佳的 2 型糖尿病患者二线治疗的疗效和安全性。
受试者被随机分配至恩格列净 25mg/利拉利汀 5mg（n=137）、恩格列净 10mg/利拉利汀 5mg（n=136）、恩格列净 25mg（n=141）、恩格列净 10mg（n=140）或利拉利汀 5mg（n=132）作为二甲双胍的附加治疗，持续 52 周。主要终点为第 24 周时 HbA1c 从基线的变化。
第 24 周时，与单独使用恩格列净或利拉利汀相比，恩格列净/利拉利汀联合治疗可显著降低 HbA1c（平均基线值为 7.90-8.02%[62.8-64.1mmol/mol]）；与基线相比的调整平均（SE）变化分别为：恩格列净 25mg/利拉利汀 5mg 组为-1.19%（0.06）（-13.1mmol/mol[0.7]），恩格列净 10mg/利拉利汀 5mg 组为-1.08%（0.06）（-11.8mmol/mol[0.7]），恩格列净 25mg 组为-0.62%（0.06）（-6.8mmol/mol[0.7]），恩格列净 10mg 组为-0.66%（0.06）（-7.2mmol/mol[0.7]），利拉利汀 5mg 组为-0.70%（0.06）（-7.6mmol/mol[0.7]）（所有比较均 P<0.001）。在这些组中，基线 HbA1c≥7%（≥53mmol/mol）的受试者分别有 61.8%、57.8%、32.6%、28.0%和 36.1%在第 24 周时 HbA1c<7%（<53mmol/mol）。疗效在第 52 周时得到维持。52 周期间，各治疗组不良事件（AE）的发生率相似（68.6-73.0%），无需要协助的低血糖 AE。
恩格列净/利拉利汀联合治疗 52 周可显著降低 HbA1c，与单一药物相比，且耐受性良好。
