Kis Janos T, Seufert Jochen, Haluzík Martin, Bonnemaire Mireille, Vera Carine, Tournay Mathilde, Freemantle Nick, Guja Cristian
Department of Internal Medicine Centrum, Szent János Hospital, Budapest, Hungary.
Division of Endocrinology and Diabetology, Department of Medicine II, Medical Center, University of Freiburg, Freiburg, Germany.
Diabetes Ther. 2024 Nov;15(11):2337-2350. doi: 10.1007/s13300-024-01644-0. Epub 2024 Sep 14.
This study aimed to evaluate the effect of baseline body mass index (BMI) and glycated hemoglobin (HbA1c) on the effectiveness and safety of initiating iGlarLixi (insulin glargine 100 U/ml and lixisenatide) in people with type 2 diabetes (T2D) in routine clinical practice.
We pooled patient-level data from 1406 people with inadequately controlled T2D, initiating a 24-week iGlarLixi treatment. Analysis sets were based on baseline BMI and HbA1c. In the BMI set, 894 (64%) people had a BMI ≥ 30 kg/m and 510 (36%) a BMI < 30 kg/m; in the HbA1c set, 615 (44%) people had an HbA1c >9%, 491 (35%) between 8 and 9%, and 298 (21%) < 8%.
After initiating iGlarLixi, HbA1c decreased in all participants, with the greatest least-squares mean reduction at 2.15% from baseline to week 24 in those with baseline HbA1c > 9% (using a mixed model for repeated measures). Overall, mean ± standard deviation body weight decreased by 1.9 ± 4.8 kg, with the most prominent loss of 2.6 ± 4.9 kg recorded in people presenting with obesity. Reported hypoglycemia rates were low across all groups.
Initiation of iGlarLixi in people with uncontrolled T2D is effective and safe in clinical practice, across different baseline HbA1c and BMI categories.
本研究旨在评估在常规临床实践中，基线体重指数（BMI）和糖化血红蛋白（HbA1c）对2型糖尿病（T2D）患者起始使用iGlarLixi（甘精胰岛素100 U/ml和利司那肽）的有效性和安全性的影响。
我们汇总了1406例T2D控制不佳患者的数据，这些患者开始了为期24周的iGlarLixi治疗。分析集基于基线BMI和HbA1c。在BMI分组中，894例（64%）患者BMI≥30 kg/m²，510例（36%）患者BMI<30 kg/m²；在HbA1c分组中，615例（44%）患者HbA1c>9%，491例（35%）患者HbA1c在8%至9%之间，298例（21%）患者HbA1c<8%。
起始使用iGlarLixi后，所有参与者的HbA1c均下降，基线HbA1c>9%的参与者从基线到第24周的最小二乘均值降幅最大，为2.15%（使用重复测量混合模型）。总体而言，平均体重±标准差下降了1.9±4.8 kg，肥胖患者体重下降最为显著，为2.6±4.9 kg。所有组报告的低血糖发生率均较低。
在临床实践中，对于T2D控制不佳的患者，无论基线HbA1c和BMI类别如何，起始使用iGlarLixi都是有效且安全的。
