Translational and Clinical Research Institute, Newcastle University, Newcastle upon Tyne, UK.
Metabolic Diseases Research Unit (UIEM), National Institute of Medical Sciences and Nutrition Salvador Zubiran (INCMNSZ), Mexico City, Mexico.
Diabetes Obes Metab. 2021 Dec;23(12):2660-2669. doi: 10.1111/dom.14518. Epub 2021 Aug 31.
To assess the efficacy and safety of iGlarLixi, a fixed-ratio combination of basal insulin glargine 100 U/mL and lixisenatide (glucagon-like peptide-1 receptor agonist) versus IDegAsp, a co-formulation of basal insulin degludec 100 U/mL with rapid-acting insulin aspart.
A systematic literature search of randomized controlled trials (RCTs) was performed. Outcomes from eligible RCTs were compared by an indirect treatment comparison using a Bayesian framework. Subanalyses of Japanese and international trials were performed.
Eight RCTs (duration 26-30 weeks) were included. Mean difference in HbA1c change with iGlarLixi exceeded that for IDegAsp: -0.64 (95% credible interval -1.01, -0.28) %-units (-7.0 [-11.0, -3.1] mmol/mol) for all trials, -0.39 (-0.55, -0.23) %-units (-4.3 [-6.0, -2.5] mmol/mol) for international, and -0.88 (-1.11, -0.64) %-units (-9.6 [-12.1, -7.0] mmol/mol) for Japanese trials. HbA1c target achievement (<7.0%-units [<53 mmol/mol]) was greater for iGlarLixi in all trials (odds ratio 2.50 [1.06, 5.56]) and Japanese trials (2.17 [1.27, 3.70]), but not in international trials (2.17 [0.42, 11.11]). Analyses suggesting differences in mean postmeal self-measured plasma glucose were significantly lower by 1.0-2.0 mmol/L (18-36 mg/dL) with iGlarLixi in all analyses. Bodyweight change was more favourable (1-2 kg) for iGlarLixi versus IDegAsp for all analyses (P < 0.05). Comparisons of hypoglycaemia were inconclusive owing to differences in definitions between studies. Adverse events were more frequent with iGlarLixi because of gastrointestinal intolerance.
iGlarLixi appears to offer clinical benefit in glucose control and bodyweight change in people needing both basal and meal-time intervention.
评估甘精胰岛素利司那肽(100U/ml 甘精胰岛素和利西那肽的固定比例组合)与德谷胰岛素门冬胰岛素(100U/ml 地特胰岛素和门冬胰岛素的预混制剂)相比的疗效和安全性。
系统检索了随机对照试验(RCT)的文献。使用贝叶斯框架的间接治疗比较比较了合格 RCT 的结果。对日本和国际试验进行了亚组分析。
纳入了 8 项 RCT(持续 26-30 周)。与 IDegAsp 相比,iGlarLixi 的 HbA1c 变化均值差值更大:所有试验为-0.64(95%可信区间-1.01,-0.28)%单位(-7.0 [-11.0,-3.1] mmol/mol),国际试验为-0.39(-0.55,-0.23)%单位(-4.3 [-6.0,-2.5] mmol/mol),日本试验为-0.88(-1.11,-0.64)%单位(-9.6 [-12.1,-7.0] mmol/mol)。所有试验(优势比 2.50 [1.06,5.56])和日本试验(2.17 [1.27,3.70])中,iGlarLixi 达到 HbA1c 目标(<7.0%-units [<53 mmol/mol])的可能性更大,但国际试验中无此情况(2.17 [0.42,11.11])。所有分析均表明,iGlarLixi 组的平均餐后自我监测血浆葡萄糖值低 1.0-2.0mmol/L(18-36mg/dL)。iGlarLixi 组的体重变化更有利(1-2kg),所有分析均具有统计学意义(P<0.05)。由于研究之间的定义不同,低血糖事件的比较结果不一致。由于胃肠道不耐受,iGlarLixi 的不良事件更为频繁。
iGlarLixi 在需要基础和餐时干预的人群中,在血糖控制和体重变化方面似乎具有临床优势。