AIM To assess the efficacy and safety of empagliflozin as add-on to insulin in Japanese patients with type 2 diabetes (T2D). MATERIALS AND METHODS This multicentre, double-blind, parallel-group study randomized Japanese patients with T2D insufficiently controlled with insulin (1:1:1) to empagliflozin 10 mg (n=89), empagliflozin 25 mg (n=90) or placebo (n=90) for 52 weeks. The primary endpoint was change from baseline in glycated haemoglobin (HbA1c) at 16 weeks. RESULTS At 16 weeks, empagliflozin 10 mg and 25 mg significantly decreased HbA1c: adjusted mean difference -0.92% (95% confidence interval [CI] -1.11, -0.73) and -1.00% (95% CI -1.18, -0.82; both P<0.0001) compared with placebo. This difference was maintained up to 52 weeks: adjusted mean difference at 52 weeks -0.90% (95% CI -1.09, -0.70) and -0.96% (95% CI -1.15, -0.77; both P<0.0001). At 52 weeks, significant improvements in fasting plasma glucose (adjusted mean difference -27.62 mg/dL [95% CI -36.15, -19.08] and -31.99 mg/dL [95% CI -40.35, -23.62]) and in body weight (-1.78 kg [95% CI -2.46, -1.10] and -1.92 kg [95% CI -2.58, -1.25]) were also seen with empagliflozin 10 mg and 25 mg compared with placebo (all P<0.0001). At 52 weeks, the frequency of adverse events (AEs) and serious AEs was similar in the three treatment groups; confirmed hypoglycaemia was reported slightly more in participants in the empagliflozin 10 mg and 25 mg groups (23.3% and 22.2% vs 14.4%). All hypoglycaemic events were mild in severity; no episodes required assistance. CONCLUSIONS In Japanese patients with insufficiently controlled T2D, adding empagliflozin 10 mg or 25 mg to insulin treatment was associated with clinically meaningful reductions in HbA1c at 16 weeks and was generally well tolerated.

中文翻译：

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恩帕格列净作为日本2型糖尿病患者胰岛素补充剂的疗效和安全性：一项随机，双盲，安慰剂对照试验。

目的评估恩帕格列净作为胰岛素补充剂在日本2型糖尿病（T2D）患者中的疗效和安全性。材料与方法这项多中心，双盲，平行组研究将胰岛素控制不充分的日本T2D患者（1：1：1）随机分为恩帕格列净10 mg（n = 89），恩帕列净25 mg（n = 90）或安慰剂（n = 90）52周。主要终点是16周时糖化血红蛋白（HbA1c）的基线变化。结果在16周时，依帕列净10 mg和25 mg可使HbA1c显着降低：调整后平均差-0.92％（95％置信区间[CI] -1.11，-0.73）和-1.00％（95％CI -1.18，-0.82;两者均P <0.0001）与安慰剂相比。该差异一直维持到52周：52周的调整后平均差异为-0.90％（95％CI -1.09，-0.70）和-0.96％（95％CI -1.15，-0.77；两者均P <0。0001）。在第52周时，空腹血糖（调整后的平均差异-27.62 mg / dL [95％CI -36.15，-19.08]和-31.99 mg / dL [95％CI -40.35，-23.62]）和体重都有明显改善与安慰剂相比，依帕列净10 mg和25 mg也观察到（-1.78 kg [95％CI -2.46，-1.10]和-1.92 kg [95％CI -2.58，-1.25]（所有P <0.0001）。在52周时，三个治疗组的不良事件（AEs）和严重AEs的发生频率相似；在10 mg和25 mg依帕列净治疗组的参与者中，证实的低血糖症发生率略高（23.3％和22.2％对14.4％）。所有降血糖事件的严重程度均为轻度；没有剧集需要帮助。结论在日本，T2D控制不充分的患者中，