Introduction This analysis aims to investigate the efficacy and safety of once-daily lixisenatide add-on treatment to basal insulin in Asian individuals with type 2 diabetes, by baseline body mass index (BMI). Research design and methods Data from all Asian participants in the placebo-controlled GetGoal-Duo 1, GetGoal-L, and GetGoal-L-C Studies were pooled and categorized according to the following BMI subgroups:<25 kg/m2, 25–<30 kg/m2 and ≥30 kg/m2. Efficacy and safety of lixisenatide versus placebo were evaluated among BMI subgroups. Multivariable regression analyses were also conducted to explore the potential influence of BMI on efficacy outcomes after adjusting for baseline characteristics. Results 555 participants were included (mean age 53.9 years, 52.4% men). No significant differences in treatment effect between the BMI subgroups were observed for the changes from baseline to 24 weeks in glycated hemoglobin (HbA1c), fasting plasma glucose, postprandial glucose (PPG), PPG excursion, body weight, BMI, and basal insulin dose with lixisenatide, as well as the change in basal insulin dose at study endpoint and the proportion of participants achieving an HbA1c <7% at 24 weeks (all p values for interaction >0.15). In the multivariable regression analysis, participants in the lowest BMI group had a smaller reduction in body weight over the 24-week treatment period relative to the highest BMI group (p = 0.023). Conclusions This post hoc analysis indicates that lixisenatide improved glycemic control regardless of baseline BMI and was well tolerated in Asian individuals unable to achieve their HbA1c target on basal insulin±oral antidiabetic drugs. Data are available upon reasonable request. Qualified researchers may request access to patient-level data and related study documents including the clinical study report, study protocol with any amendments, blank case report form, statistical analysis plan, and dataset specifications. Patient-level data will be anonymized, and study documents will be redacted to protect the privacy of trial participants. Further details on Sanofi’s data sharing criteria, eligible studies, and process for requesting access can be found at: .

中文翻译：

---

在患有 2 型糖尿病和不同体重指数的亚洲人中，利西拉肽作为基础胰岛素的附加治疗是有效和安全的：来自 GetGoal 研究的数据汇总分析

引言 本分析旨在通过基线体重指数 (BMI) 研究每天一次 lixisenatide 附加治疗对亚洲 2 型糖尿病患者基础胰岛素的疗效和安全性。研究设计和方法 根据以下 BMI 亚组汇总和分类安慰剂对照 GetGoal-Duo 1、GetGoal-L 和 GetGoal-LC 研究中所有亚洲参与者的数据：<25 kg/m2、25–<30 kg /m2 和 ≥30 kg/m2。在 BMI 亚组中评估了利西拉来与安慰剂的疗效和安全性。还进行了多变量回归分析，以探讨在调整基线特征后 BMI 对疗效结果的潜在影响。结果 包括 555 名参与者（平均年龄 53.9 岁，男性占 52.4%）。在糖化血红蛋白 (HbA1c)、空腹血糖、餐后血糖 (PPG)、PPG 偏移、体重、BMI 和基础胰岛素剂量从基线到 24 周的变化方面，未观察到 BMI 亚组之间的治疗效果存在显着差异。 lixisenatide，以及研究终点时基础胰岛素剂量的变化，以及在 24 周时达到 HbA1c <7% 的参与者比例（相互作用的所有 p 值 >0.15）。在多变量回归分析中，相对于最高 BMI 组，最低 BMI 组的参与者在 24 周的治疗期内体重下降幅度较小（p = 0.023）。结论 这项事后分析表明，利西拉来改善了血糖控制，而不管基线 BMI 是多少，并且在无法通过基础胰岛素 ± 口服抗糖尿病药物达到其 HbA1c 目标的亚洲个体中具有良好的耐受性。可应合理要求提供数据。合格的研究人员可以要求访问患者级别的数据和相关研究文件，包括临床研究报告、带有任何修订的研究方案、空白病例报告表、统计分析计划和数据集规范。患者级别的数据将被匿名化，研究文件将被编辑以保护试验参与者的隐私。有关赛诺菲数据共享标准、合格研究和请求访问流程的更多详细信息，请访问：合格的研究人员可以要求访问患者级别的数据和相关研究文件，包括临床研究报告、带有任何修订的研究方案、空白病例报告表、统计分析计划和数据集规范。患者级别的数据将被匿名化，研究文件将被编辑以保护试验参与者的隐私。有关赛诺菲数据共享标准、合格研究和请求访问流程的更多详细信息，请访问：合格的研究人员可以要求访问患者级别的数据和相关研究文件，包括临床研究报告、带有任何修订的研究方案、空白病例报告表、统计分析计划和数据集规范。患者级别的数据将被匿名化，研究文件将被编辑以保护试验参与者的隐私。有关赛诺菲数据共享标准、合格研究和请求访问流程的更多详细信息，请访问：.