Frías Juan P, Ratzki-Leewing Alexandria, Dex Terry, Meneghini Luigi, Rodrigues Amélie, Shah Viral N
Biomea Fusion, Redwood City, California, USA.
University of Maryland Institute for Health Computing, Bethesda, Maryland, USA.
Diabetes Obes Metab. 2025 Apr;27(4):2173-2182. doi: 10.1111/dom.16214. Epub 2025 Feb 4.
People with type 2 diabetes (T2D) and glycated haemoglobin (HbA1c) ≥9% may benefit from fixed-ratio combination therapies such as iGlarLixi (insulin glargine 100 U/mL and lixisenatide 33 μg/mL). Use of continuous glucose monitoring (CGM) is recommended, but data are lacking to assess the impact of iGlarLixi in individuals with HbA1c ≥9%.
Soli-CGM (NCT05114590) was a 16-week, multicentre, open-label study evaluating the efficacy of once-daily iGlarLixi using blinded CGM-based metrics in insulin-naive adults with HbA1c ≥9%-13% who were receiving ≥2 oral antihyperglycaemic agents (OADs) ± glucagon-like peptide-1 receptor agonists (GLP-1 RAs). The primary outcome was the change from baseline to week 16 in percent time in range (TIR; 70-180 mg/dL). Secondary outcomes included change in mean daily blood glucose (BG), maximum postprandial glucose 4 h post-breakfast (PPG-4 h), and time above range (TAR; >180 mg/dL). On-treatment hypoglycaemia was assessed.
The study enrolled 124 participants (mean age, 55.6 years; HbA1c, 10.2%). Sixteen weeks of treatment with iGlarLixi improved TIR (+26.2%), mean BG (-52.5 mg/dL), maximum PPG-4 h (-73.7 mg/dL), and TAR (-28.7%); all p < 0.001. Rates of American Diabetes Association level 1 (BG <70 but ≥54 mg/dL) and level 2 (BG <54 mg/dL) hypoglycaemia were reported as 1.4 and 0.6 events per person-year, respectively. No level 3 events (requiring assistance) were reported.
In people with T2D suboptimally controlled on ≥2 OADs ± GLP-1 RAs, 16 weeks of treatment with iGlarLixi significantly improved TIR and reduced TAR without severe hypoglycaemia.
2型糖尿病（T2D）且糖化血红蛋白（HbA1c）≥9%的患者可能从固定比例联合疗法中获益，如iGlarLixi（甘精胰岛素100 U/mL和利司那肽33 μg/mL）。建议使用连续血糖监测（CGM），但缺乏评估iGlarLixi对HbA1c≥9%个体影响的数据。
Soli-CGM（NCT05114590）是一项为期16周的多中心开放标签研究，在未使用过胰岛素、HbA1c≥9%-13%且正在接受≥2种口服降糖药（OADs）±胰高血糖素样肽-1受体激动剂（GLP-1 RAs）治疗的成年患者中，使用基于CGM的盲法指标评估每日一次iGlarLixi的疗效。主要结局是从基线到第16周血糖处于目标范围时间百分比（TIR；70-180 mg/dL）的变化。次要结局包括平均每日血糖（BG）变化、早餐后4小时最大餐后血糖（PPG-4h）以及高于目标范围时间（TAR；>180 mg/dL）。评估治疗期间的低血糖情况。
该研究纳入了124名参与者（平均年龄55.6岁；HbA1c 10.2%）。iGlarLixi治疗16周可改善TIR（+26.2%）、平均BG（-52.5 mg/dL）、最大PPG-4h（-73.7 mg/dL）和TAR（-28.7%）；所有p<0.001。美国糖尿病协会1级（BG<70但≥54 mg/dL）和2级（BG<54 mg/dL）低血糖发生率分别报告为每人每年1.4次和0.6次事件。未报告3级事件（需要协助）。
在接受≥2种OADs±GLP-1 RAs治疗但控制不佳的T2D患者中，iGlarLixi治疗16周可显著改善TIR并降低TAR，且无严重低血糖发生。
