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首页> 外文期刊>Journal of Clinical Medicine Research >Efficacy and Safety of Ipragliflozin in Japanese Patients With Type 2 Diabetes: Interim Outcome of the ASSIGN-K Study
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Efficacy and Safety of Ipragliflozin in Japanese Patients With Type 2 Diabetes: Interim Outcome of the ASSIGN-K Study

机译：依普列净在日本2型糖尿病患者中的疗效和安全性：ASSIGN-K研究的中期结果

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Background: Ipragliflozin is a sodium-glucose co-transporter 2 inhibitor that can improve glycemic control and reduce body weight and blood pressure in patients with type 2 diabetes mellitus (T2DM). We evaluated the efficacy and safety of ipragliflozin in the real-world clinical setting, with a focus on the changes of body composition up to 3 months of treatment.Methods: This was a prospective multicenter interventional trial. We investigated changes of the blood pressure, body composition, blood glucose, hemoglobin A1c (HbA1c), ketone bodies, lipids, and insulin after treatment with ipragliflozin (50 - 100 mg/day) for 12 weeks in Japanese patients with T2DM who showed poor glycemic control despite receiving diet and exercise therapy with or without oral antidiabetic drugs for more than 12 weeks.Results: Two hundred and fifty-seven subjects were included in the efficacy analysis up to 12 weeks of treatment and 301 subjects were included in the safety analysis. From baseline to 12 weeks, HbA1c showed a change of -0.68% (95% confidence interval (CI): -0.83, -0.53) and fasting blood glucose showed a change of -23.9 mg/dL (95% CI: -30.5, -17.2), with both parameters displaying a significant reduction (P < 0.001). The difference of body weight from baseline was -1.82 kg (95% CI: -2.14, -1.50), and it also showed significant reduction (P < 0.001). Analysis of body composition revealed that body fat changed by -1.46 kg (95% CI: -1.79, -1.14, P < 0.001) and body water changed by -0.37 kg (95% CI: -0.60, -0.14, P < 0.01). Laboratory tests demonstrated improvement of liver function and the lipid profile. Adverse events (AEs) occurred in 22.6% of the subjects, with frequent events being vulvovaginal candidiasis in 2.7% and cystitis in 2.0%. Serious AEs occurred in three subjects.Conclusions: In patients with T2DM, ipragliflozin improved glycemic control after 1 month of treatment and caused weight loss by reducing body fat more than body water.J Clin Med Res. 2016;8(2):116-125doi: http://dx.doi.org/10.14740/jocmr2417wCorrection in J Clin Med Res. 2016;8(3):267-267, doi: http://dx.doi.org/10.14740/jocmr2417wc1
机译：背景：伊普列净是一种钠-葡萄糖共转运蛋白2抑制剂，可改善2型糖尿病（T2DM）患者的血糖控制并降低体重和血压。我们评估了依普列净在现实世界中的临床疗效和安全性，重点研究了长达3个月的治疗后人体成分的变化。方法：这是一项前瞻性多中心介入试验。我们调查了在日本表现出可怜的T2DM患者中服用伊普列净（50-100 mg / day）12周后血压，身体成分，血糖，血红蛋白A1c（HbA1c），酮体，脂质和胰岛素的变化尽管接受饮食和运动疗法（有或没有口服抗糖尿病药）超过12周仍进行血糖控制。结果：257名受试者被纳入疗效分析，直至治疗12周，安全性分析纳入301名受试者。从基线到12周，HbA1c的变化为-0.68％（95％的置信区间（CI）：-0.83，-0.53），空腹血糖的变化为-23.9 mg / dL（95％的CI：-30.5， -17.2），两个参数均显示出显着降低（P <0.001）。与基线的体重差异为-1.82千克（95％CI：-2.14，-1.50），并且体重也显着降低（P <0.001）。人体成分分析表明，人体脂肪变化了-1.46千克（95％CI：-1.79，-1.14，P <0.001），而体内水变化了-0.37 kg（95％CI：-0.60，-0.14，P <0.01） ）。实验室测试证明肝功能和血脂水平得到改善。不良事件（AEs）发生在22.6％的受试者中，频繁发生的事件是2.7％的外阴念珠菌病和2.0％的膀胱炎。在三名受试者中发生了严重的AE。结论：在2型糖尿病患者中，伊格列净改善了1个月的治疗后的血糖控制，并通过减少体内脂肪超过了体内水分而导致了体重减轻。 2016; 8（2）：116-125doi：http://dx.doi.org/10.14740/jocmr2417w在J Clin Med Res。 2016; 8（3）：267-267，doi：http://dx.doi.org/10.14740/jocmr2417wc1

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