Diabetes is one of the world’s most widespread conditions, and diabetic patients are among the most likely to engage in fierce battles with this chronic disease. Which group should be added-on as a dual therapy for Egyptian patients with type 2 diabetes and inadequate glycemic management, HbA1c ≥ 7.0% and ≤ 10% (≥ 53 and ≤ 86 mmol/mol), following not less than 3 months of metformin and diet therapy, is still up for debate. Based on this ambiguity, we designed our study to compare the safety and efficacy of sitagliptin 50 mg (n = 85) with empagliflozin 12.5 mg (n = 85) twice daily as an adjunctive therapy to metformin and diet for a further 12 weeks. HbA1c after 12 weeks of open-label therapy was the major outcome measure. After 12 weeks of treatment, empagliflozin drastically lowered HbA1c, FPG, PP, body weight, and triglycerides from baseline while significantly increasing LDL, total cholesterol, and HDL. On the other hand, sitagliptin significantly reduced FPG, PP (with a no discernable alteration in HbA1c), body weight, and triglycerides while significantly increasing HDL (P ≤ 0.001 for all comparisons). Comparing the two groups, empagliflozin significantly reduced HbA1c, FPG, and PP while significantly increasing LDL and triglycerides than sitagliptin (P < 0.001 for all except FPG, P = 0.005). More patients receiving empagliflozin 12.5 mg than sitagliptin 50 mg twice daily reported adverse events during open-label treatment (11.8% vs. 8.2%, respectively). In type 2 diabetic Egyptian patients uncontrolled with metformin and diet, empagliflozin was superior to sitagliptin as regards glycemic control, weight, and SBP/DBP reduction.

中文翻译：

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恩格列净与西格列汀作为附加双重疗法治疗二甲双胍控制不佳的埃及 2 型糖尿病患者：一项为期 12 周的随机、开放标签、平行组试验

糖尿病是世界上最普遍的疾病之一，糖尿病患者是最有可能与这种慢性疾病进行激烈斗争的人群之一。对于患有 2 型糖尿病且血糖管理不充分、HbA1c ≥ 7.0% 且≤ 10%（≥ 53 且≤ 86 mmol/mol）且二甲双胍治疗不少于 3 个月的埃及患者，应添加哪组作为双重治疗和饮食疗法，仍有争议。基于这种模糊性，我们设计了研究来比较西他列汀 50 mg (n = 85) 与恩格列净 12.5 mg (n = 85) 每日两次作为二甲双胍和饮食的辅助治疗，持续 12 周的安全性和有效性。12 周开放标签治疗后的 HbA1c 是主要结果指标。治疗 12 周后，恩格列净较基线大幅降低 HbA1c、FPG、PP、体重和甘油三酯，同时显着增加 LDL、总胆固醇和 HDL。另一方面，西他列汀显着降低 FPG、PP（HbA1c 没有明显变化）、体重和甘油三酯，同时显着增加 HDL（所有比较 P ≤ 0.001）。比较两组，恩格列净比西格列汀显着降低 HbA1c、FPG 和 PP，同时显着增加 LDL 和甘油三酯（除 FPG 外，所有组 P < 0.001，P = 0.005）。在开放标签治疗期间，接受恩格列净 12.5 mg 治疗的患者报告的不良事件多于接受西他列汀 50 mg 每日两次治疗的患者（分别为 11.8% 和 8.2%）。在使用二甲双胍和饮食无法控制的埃及 2 型糖尿病患者中，恩格列净在血糖控制、体重和收缩压/舒张压降低方面优于西格列汀。