Abstract：
OBJECTIVE: Add-on of basal insulin (BI) to intensify the ongoing therapy with glucagon-like peptide 1 receptor agonist (GLP-1 RA) is recommended, but it is unclear if free or fixed combination of BI and GLP-1 RA produce similar outcomes. A retrospective comparative effectiveness analysis of the add-on of glargine 300 U/mL (Gla-300) to ongoing GLP-1 RA vs. switch to fixed ratio combination of degludec and liraglutide (iDegLira) was performed.
RESULTS: Real-world data collected in electronic medical records by 32 Italian diabetes clinics. Propensity score (PS) adjustment was applied to assess changes in glycated hemoglobin (HbA1c), fasting blood glucose (FBG), body weight, and BI dose after 6 months from Gla-300 or iDegLira initiation. Compared to iDegLira group (N = 260), Gla-300+GLP-1 RA group (N = 255) had older age and higher levels of HbA1c (9.1 vs. 8.9%). After 6 months, statistically significant greater FBG improvement [estimated mean difference and 95% confidence intervals: -24.05 mg/dl (-37.04; -11.06; p = 0.0003) and BI dose increase [+0.03 U/kg (95%CI 0.00; 0.06); p = 0.009] were found in the free vs. fixed combination group, although low doses of BI (0.2 U/kg) were reached in both groups. Trends of larger HbA1c and body weight reductions with the free combination were also found, without reaching the statistical significance.
CONCLUSIONS: Although inertia in insulin initiation and titration was documented in both groups, higher benefit on FBG control was obtained with free vs. fixed combination, likely due to a better titration of BI and GLP-1 RA.
RESULTS: Real-world data collected in electronic medical records by 32 Italian diabetes clinics. Propensity score (PS) adjustment was applied to assess changes in glycated hemoglobin (HbA1c), fasting blood glucose (FBG), body weight, and BI dose after 6 months from Gla-300 or iDegLira initiation. Compared to iDegLira group (N = 260), Gla-300+GLP-1 RA group (N = 255) had older age and higher levels of HbA1c (9.1 vs. 8.9%). After 6 months, statistically significant greater FBG improvement [estimated mean difference and 95% confidence intervals: -24.05 mg/dl (-37.04; -11.06; p = 0.0003) and BI dose increase [+0.03 U/kg (95%CI 0.00; 0.06); p = 0.009] were found in the free vs. fixed combination group, although low doses of BI (0.2 U/kg) were reached in both groups. Trends of larger HbA1c and body weight reductions with the free combination were also found, without reaching the statistical significance.
CONCLUSIONS: Although inertia in insulin initiation and titration was documented in both groups, higher benefit on FBG control was obtained with free vs. fixed combination, likely due to a better titration of BI and GLP-1 RA.
摘要：
目的：建议添加基础胰岛素（BI）以加强胰高血糖素样肽1受体激动剂（GLP-1RA）的持续治疗，但尚不清楚BI和GLP-1RA的游离或固定组合是否产生相似的结局.对正在进行的GLP-1RA添加甘精300U/mL（Gla-300）的回顾性比较有效性分析转换为degludec和利拉鲁肽的固定比例组合（iDegLira）。
结果：由32个意大利糖尿病诊所收集的电子病历中的真实世界数据。倾向评分（PS）调整用于评估糖化血红蛋白（HbA1c）的变化，空腹血糖（FBG），体重,从Gla-300或iDegLira开始6个月后的BI剂量。与iDegLira组(N=260)相比，Gla-300+GLP-1RA组（N=255）年龄较大，HbA1c水平较高（9.1vs.8.9%）。六个月后,有统计学意义的更大的FBG改善[估计的平均差异和95％置信区间：-24.05mg/dl（-37.04;-11.06;p=0.0003）和BI剂量增加[0.03U/kg（95CI;0.06）;p=0.009]在自由vs.固定组合组，尽管两组均达到低剂量BI（0.2U/kg）。还发现了自由组合的更大的HbA1c和体重减轻的趋势，没有达到统计学意义。
结论：尽管两组均有胰岛素启动和滴定的惯性，FBG控制获得了更高的好处固定组合,可能是由于BI和GLP-1RA的滴定更好。
结果：由32个意大利糖尿病诊所收集的电子病历中的真实世界数据。倾向评分（PS）调整用于评估糖化血红蛋白（HbA1c）的变化，空腹血糖（FBG），体重,从Gla-300或iDegLira开始6个月后的BI剂量。与iDegLira组(N=260)相比，Gla-300+GLP-1RA组（N=255）年龄较大，HbA1c水平较高（9.1vs.8.9%）。六个月后,有统计学意义的更大的FBG改善[估计的平均差异和95％置信区间：-24.05mg/dl（-37.04;-11.06;p=0.0003）和BI剂量增加[0.03U/kg（95CI;0.06）;p=0.009]在自由vs.固定组合组，尽管两组均达到低剂量BI（0.2U/kg）。还发现了自由组合的更大的HbA1c和体重减轻的趋势，没有达到统计学意义。
结论：尽管两组均有胰岛素启动和滴定的惯性，FBG控制获得了更高的好处固定组合,可能是由于BI和GLP-1RA的滴定更好。
