在一项前瞻性观察性试验中，iGlarLixi对基础胰岛素和口服抗糖尿病药物治疗未达标的2型糖尿病患者的有效性和安全性。
Effectiveness and safety of iGlarLixi in people with type 2 diabetes not at target on basal insulin and oral antidiabetic therapy in a prospective observational trial.
作者信息
Seufert Jochen, Wiesner Tobias, Pegelow Katrin, Kenzler Julia, Pfohl Martin
机构信息
Division of Endocrinology and Diabetology, Department of Medicine II, Medical Center-University of Freiburg, Faculty of Medicine, University of Freiburg, Freiburg, Germany.
Medical Care Center, Metabolic Medicine Leipzig, Leipzig, Germany.
出版信息
Diabetes Obes Metab. 2025 Mar;27(3):1526-1535. doi: 10.1111/dom.16161. Epub 2025 Jan 6.
AIMS
This study assessed efficacy and safety of the fixed ratio combination iGlarLixi 100/33 (insulin glargine 100 U/mL plus lixisenatide 33 μg/mL) in people with type 2 diabetes (PwT2D) in daily clinical practice.
MATERIALS AND METHODS
This non-interventional, multicentre, prospective, single-arm 24-week study documented PwT2D with an HbA1c of 7.5%-10.0%, currently treated with a basal insulin supported oral therapy (BOT) in German primary care facilities, after the physician had decided to change treatment to iGlarLixi 100/33, independent of study participation. Primary end-point was the absolute change in HbA1c (%) from baseline.
RESULTS
Of 93 participants included, 70 comprised the full analysis set for efficacy assessment. Approximately 24 weeks after switching to iGlarLixi 100/33 HbA1c (mean ± standard deviation) changed from 8.52 ± 0.82% by -0.74 ± 0.81% to 7.74 ± 0.76%, FPG from 174.3 ± 44.6 mg/dL (9.67 ± 2.48 mmol/L) by -32.9 ± 46.3 mg/dL (-1.83 ± 2.57 mmol/L) to 141.4 ± 34.1 mg/dL (7.85 ± 1.89 mmol/L) and body weight from 104.3 ± 22.5 kg by -3.0 ± 7.5 kg to 101.3 ± 21.6 kg (all p < 0.01). Furthermore, use of DPP4 inhibitors was significantly reduced from 34.8% to 6.8% of participants. Derived (from 7-point self-measured plasma glucose) time in range (TIR) increased and time above range (TAR) decreased after 24 weeks to target ranges (all p < 0.05). Flash glucose monitoring data of 20 patients showed similar patterns for TIR and TAR, respectively, and a reduction in time below range (p = 0.007). Hypoglycaemia events did not change significantly and were low in number. No severe hypoglycaemia was reported.
CONCLUSIONS
Modifying antiglycaemic treatment from a BOT regimen to iGlarLixi 100/33 in suboptimal controlled PwT2D in daily clinical practice improved glycaemic control without increasing hypoglycaemia and with favourable body weight change.
目的
本研究评估了固定比例复方制剂iGlarLixi 100/33（甘精胰岛素100 U/mL加利司那肽33 μg/mL）在日常临床实践中对2型糖尿病患者（T2D患者）的疗效和安全性。
材料与方法
这项非干预性、多中心、前瞻性、单臂24周研究记录了糖化血红蛋白（HbA1c）为7.5%-10.0%的T2D患者，这些患者目前在德国初级保健机构接受基础胰岛素支持的口服治疗（BOT），在医生决定将治疗改为iGlarLixi 100/33后，独立于研究参与情况。主要终点是HbA1c（%）相对于基线的绝对变化。
结果
纳入的93名参与者中，70名构成了疗效评估的完整分析集。转换为iGlarLixi 100/33约24周后，HbA1c（平均值±标准差）从8.52±0.82%下降了-0.74±0.81%至7.74±0.76%，空腹血糖（FPG）从174.3±44.6 mg/dL（9.67±2.48 mmol/L）下降了-32.9±46.3 mg/dL（-1.83±2.57 mmol/L）至141.4±34.1 mg/dL（7.85±1.89 mmol/L），体重从104.3±22.5 kg下降了-3.0±7.5 kg至101.3±21.6 kg（所有P<0.0１）。此外，使用二肽基肽酶4（DPP4）抑制剂的参与者比例从34.8%显著降至6.8%。24周后，（根据7点自我测量的血浆葡萄糖得出的）血糖达标时间（TIR）增加，高于目标范围的时间（TAR）减少（所有P<0.05）。20名患者的动态血糖监测数据显示TIR和TAR分别有类似模式，且低于目标范围的时间减少（P=0.007）。低血糖事件无显著变化且数量较少。未报告严重低血糖事件。
结论
在日常临床实践中，将血糖控制欠佳的T2D患者的抗血糖治疗方案从BOT改为iGlarLixi 100/33可改善血糖控制，且不增加低血糖风险，同时体重变化有利。
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