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Abstract：
OBJECTIVE: The prevalence and pathophysiological background of type 2 diabetes mellitus vary across ethnicities, and can affect treatment responses. Adding lixisenatide to basal insulin (BI) in type 2 diabetes mellitus patients has shown improvements in glycated hemoglobin (HbA1c) and postprandial glycemic (PPG) excursions, without increasing hypoglycemic events. We aim to compare the efficacy of lixisenatide in Asian and white patients inadequately controlled with basal insulin.
METHODS: An individual-level pooled analysis of two multi-national phase III studies, GetGoal-L and GetGoal-L-C, was carried out to assess the efficacy of lixisenatide versus placebo as an add-on treatment to BI ± metformin in Asian and white patients with type 2 diabetes mellitus. Change in HbA1c, 2-h PPG and PPG excursion were analyzed, along with possible predictors of glycemic control.
RESULTS: Pooled data showed that baseline characteristics were similar between Asian and white patients with the exception of bodyweight, body mass index and BI dose being higher in white patients. After 24 weeks, lixisenatide reduced HbA1c in both ethnic groups, with no statistically significant difference between the two groups (Asian patients least squares mean difference -0.49, 95% confidence interval -0.68 to - 0.30 and white patients least squares mean difference -0.45, 95% confidence interval -0.63 to - 0.26; P = 0.6287). Similarly, no significant difference was found in 2-h PPG reduction between both groups (least squares mean difference for Asian vs white patients: -3.37 vs -3.93; P = 0.3203). Treatment with lixisenatide contributed to HbA1c reduction of -0.56% after adjustment of baseline HbA1c level in Asian patients, and -0.41% in white patients.
CONCLUSIONS: Adding lixisenatide to BI significantly reduced HbA1c and 2-h PPG levels in both Asian and white participants with type 2 diabetes mellitus. No differences in treatment effect were observed between the two populations.
METHODS: An individual-level pooled analysis of two multi-national phase III studies, GetGoal-L and GetGoal-L-C, was carried out to assess the efficacy of lixisenatide versus placebo as an add-on treatment to BI ± metformin in Asian and white patients with type 2 diabetes mellitus. Change in HbA1c, 2-h PPG and PPG excursion were analyzed, along with possible predictors of glycemic control.
RESULTS: Pooled data showed that baseline characteristics were similar between Asian and white patients with the exception of bodyweight, body mass index and BI dose being higher in white patients. After 24 weeks, lixisenatide reduced HbA1c in both ethnic groups, with no statistically significant difference between the two groups (Asian patients least squares mean difference -0.49, 95% confidence interval -0.68 to - 0.30 and white patients least squares mean difference -0.45, 95% confidence interval -0.63 to - 0.26; P = 0.6287). Similarly, no significant difference was found in 2-h PPG reduction between both groups (least squares mean difference for Asian vs white patients: -3.37 vs -3.93; P = 0.3203). Treatment with lixisenatide contributed to HbA1c reduction of -0.56% after adjustment of baseline HbA1c level in Asian patients, and -0.41% in white patients.
CONCLUSIONS: Adding lixisenatide to BI significantly reduced HbA1c and 2-h PPG levels in both Asian and white participants with type 2 diabetes mellitus. No differences in treatment effect were observed between the two populations.
摘要：
目的：2型糖尿病的患病率和病理生理背景因种族而异，并可能影响治疗反应。在2型糖尿病患者的基础胰岛素（BI）中添加利西拉来显示糖化血红蛋白（HbA1c）和餐后血糖（PPG）偏移的改善，不会增加低血糖事件。我们旨在比较利西拉来在基础胰岛素控制不足的亚洲和白人患者中的疗效。
方法：两项跨国III期研究的个体水平汇总分析，GetGoal-L和GetGoal-L-C,在亚洲和白种人2型糖尿病患者中，进行了利西拉来作为BI±二甲双胍附加治疗的疗效评估。HbA1c变化,分析了2小时PPG和PPG偏移，以及血糖控制的可能预测因素。
结果：汇总数据显示，除体重外，亚洲和白人患者的基线特征相似，白人患者的体重指数和BI剂量较高。24周后,利西拉来降低两个种族的HbA1c，两组间差异无统计学意义(亚洲患者最小二乘平均差-0.49,95%置信区间-0.68~-0.30,白人患者最小二乘平均差-0.45,95%置信区间-0.63~-0.26;P=0.6287)。同样，两组患者在2小时PPG降低方面无显著差异(亚洲患者与白人患者的最小二乘平均差:-3.37vs-3.93;P=0.3203).利西拉来治疗有助于亚洲患者调整基线HbA1c水平后HbA1c降低-0.56%，白人患者为-0.41%。
结论：在具有2型糖尿病的亚洲和白人参与者中，向BI中加入利西拉肽可显著降低HbA1c和2小时PPG水平。在两个群体之间没有观察到治疗效果的差异。
方法：两项跨国III期研究的个体水平汇总分析，GetGoal-L和GetGoal-L-C,在亚洲和白种人2型糖尿病患者中，进行了利西拉来作为BI±二甲双胍附加治疗的疗效评估。HbA1c变化,分析了2小时PPG和PPG偏移，以及血糖控制的可能预测因素。
结果：汇总数据显示，除体重外，亚洲和白人患者的基线特征相似，白人患者的体重指数和BI剂量较高。24周后,利西拉来降低两个种族的HbA1c，两组间差异无统计学意义(亚洲患者最小二乘平均差-0.49,95%置信区间-0.68~-0.30,白人患者最小二乘平均差-0.45,95%置信区间-0.63~-0.26;P=0.6287)。同样，两组患者在2小时PPG降低方面无显著差异(亚洲患者与白人患者的最小二乘平均差:-3.37vs-3.93;P=0.3203).利西拉来治疗有助于亚洲患者调整基线HbA1c水平后HbA1c降低-0.56%，白人患者为-0.41%。
结论：在具有2型糖尿病的亚洲和白人参与者中，向BI中加入利西拉肽可显著降低HbA1c和2小时PPG水平。在两个群体之间没有观察到治疗效果的差异。
