AIMS To assess efficacy and safety of fixed-ratio (1:1) combination insulin glargine and lixisenatide (iGlarLixi) compared to insulin glargine U100 (iGlar), with metformin, in Japanese patients with type 2 diabetes mellitus (T2DM) inadequately controlled on basal insulin and oral antidiabetic drugs (OADs). MATERIALS AND METHODS This 26-week, randomized, open-label study compared iGlarLixi to iGlar, both with metformin in adult Japanese patients with T2DM and hemoglobin (Hb) A1c ≥7.5% to ≤9.5%, treated with basal insulin and 1 or 2 OADs. 512 patients were randomized after a 12-week run-in, when iGlar was introduced and/or further titrated and OADs other than metformin were stopped. The primary endpoint was change in HbA1c from baseline to week 26. RESULTS iGlarLixi (n=255) demonstrated significantly greater reductions in HbA1c (-1.27%) than iGlar (n=257, -0.53%) (LS mean difference: -0.74%, P <0.0001) at week 26, confirming the superiority of iGlarLixi. Significantly more iGlarLixi patients reached target HbA1c <7% at week 26 (51.8% vs. 16.0% for iGlar). iGlarLixi patients lost weight in contrast to iGlar patients (-0.51kg vs. +0.55kg). Documented symptomatic hypoglycemia (plasma glucose ≤3.9mmol/L) was observed in 18.8% of iGlarLixi patients vs. 16.7% of iGlar patients. iGlarLixi patients had more gastrointestinal-related adverse events than iGlar patients (33.3% vs. 8.6%), primarily nausea (16.9% vs. 0.8%). However, the treatment was generally well-tolerated. CONCLUSIONS A once-daily injection of iGlarLixi with metformin is an effective, well-tolerated, and simple therapeutic intervention providing significant improvement in glycemic control in Japanese patients with T2DM inadequately controlled on basal insulin and up to two OADs. Clinical Trial Number: NCT02752412 This article is protected by copyright. All rights reserved.

中文翻译：

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甘精胰岛素/立克塞那肽固定比例组合（iGlarLixi）在基础胰岛素和口服降糖药控制不良的日本2型糖尿病患者中的疗效和安全性：LixiLan JP-L随机临床试验。

目的评估在基础剂量控制不充分的日本2型糖尿病（T2DM）患者中，固定比例（1：1）的甘精胰岛素和利西拉肽（iGlarLixi）与甘精胰岛素U100（iGlar）联合二甲双胍的疗效和安全性胰岛素和口服降糖药（OAD）。材料与方法这项为期26周的随机，开放标签研究对日本成年T2DM和血红蛋白（Hb）A1c≥7.5％至≤9.5％的成年日本患者使用基础胰岛素和1或2治疗了iGlarLixi和iGlar OAD。在引入iGlar和/或进一步滴定并停止使用除二甲双胍以外的OAD的12周磨合后，将512例患者随机分组。主要终点是从基线到第26周HbA1c的变化。结果iGlarLixi（n = 255）证明HbA1c的减少量更大（-1。在第26周时比iGlar（n = 257，-0.53％）（LS平均差异：-0.74％，P <0.0001）高27％，证实了iGlarLixi的优越性。在第26周，更多的iGlarLixi患者达到HbA1c <7％的目标（iGlar为51.8％，而1G为16.0％）。与iGlar患者相比，iGlarLixi患者减轻了体重（-0.51kg对+ 0.55kg）。记录在案的症状性低血糖症（血浆葡萄糖≤3.9mmol/ L）在iGlarLixi患者中为18.8％，而在iGlar患者中为16.7％。iGlarLixi患者的胃肠道相关不良事件要多于iGlar患者（33.3％对8.6％），主要是恶心（16.9％对0.8％）。但是，该治疗通常耐受良好。结论每天一次向iGlarLixi注射二甲双胍是一种有效，耐受性良好，和简单的治疗性干预措施可大大改善日本对基础胰岛素和最多两个OAD的控制不充分的T2DM患者的血糖控制。临床试验编号：NCT02752412本文受版权保护。版权所有。