Frank Riddick Diabetes Institute, Department of Endocrinology, Ochsner Medical Center, New Orleans, LA
Dallas Diabetes Research Center, Dallas, TX.
Diabetes Care. 2021 Mar;44(3):774-780. doi: 10.2337/dc20-2023. Epub 2021 Jan 19.
In the LixiLan-G trial, switching to iGlarLixi, a once-daily titratable fixed-ratio combination of insulin glargine 100 units/mL and the glucagon-like peptide 1 receptor agonist (GLP-1 RA) lixisenatide, improved glucose control in type 2 diabetes uncontrolled with GLP-1 RAs over 26 weeks versus continuing prior GLP-1 RA. A prespecified, 26-week, single-arm extension of LixiLan-G aimed to determine the durability of iGlarLixi efficacy and safety over 52 weeks.
Participants with type 2 diabetes uncontrolled by GLP-1 RAs (glycated hemoglobin [HbA] 7-9% [53-75 mmol/mol]) were initially randomized to switch to iGlarLixi or continue prior GLP-1 RA. Those randomized to iGlarLixi who completed the 26-week primary end point period could continue iGlarLixi open-label treatment over a 26-week extension to assess durability of efficacy and safety.
Glycemic control achieved with iGlarLixi at week 26 (mean HbA 6.7% [50 mmol/mol]) was maintained at week 52 (mean HbA 6.7% [50 mmol/mol]; mean ± SD change from baseline at week 52: -1.0 ± 0.9% [11 ± 10 mmol/mol]). Proportions of participants reaching HbA <7% (53 mmol/mol) with iGlarLixi were similar at week 26 (62%) and 52 (64%), as were those reaching this target without documented symptomatic (<3.0 mmol/L) hypoglycemia (57% and 58%). Safety of iGlarLixi was similar at weeks 26 and 52, with low rates of documented symptomatic hypoglycemia and gastrointestinal events.
The efficacy and safety of iGlarLixi at the end of the 26-week randomized treatment period was maintained over the 26-week extension period in the LixiLan-G trial.
在 LixiLan-G 试验中，与继续使用 GLP-1RA 相比，将每日一次可滴定的固定比例胰岛素 glargine 100 单位/毫升和胰高血糖素样肽 1 受体激动剂（GLP-1RA）利西那肽的固定剂量复方制剂 iGlarLixi 转换，可改善 26 周内未能控制 GLP-1RA 的 2 型糖尿病患者的血糖控制。LixiLan-G 的一个预先指定的、26 周的单臂扩展旨在确定 iGlarLixi 在 52 周内的疗效和安全性的持久性。
未能控制 GLP-1RA 的 2 型糖尿病患者（糖化血红蛋白[HbA]7-9%[53-75mmol/mol]）最初被随机分配至转换为 iGlarLixi 或继续使用先前的 GLP-1RA。那些完成了 26 周主要终点期的随机分配至 iGlarLixi 的患者可以继续接受 iGlarLixi 的开放标签治疗，持续 26 周的扩展期，以评估疗效和安全性的持久性。
在第 26 周（平均 HbA 6.7%[50mmol/mol]）时，使用 iGlarLixi 达到的血糖控制在第 52 周（平均 HbA 6.7%[50mmol/mol]；第 52 周时自基线的平均变化：-1.0±0.9%[11±10mmol/mol]）保持不变。第 26 周（62%）和第 52 周（64%）时，使用 iGlarLixi 达到 HbA<7%（53mmol/mol）的患者比例相似，未记录到有症状（<3.0mmol/L）的低血糖症的患者比例也相似（57%和 58%）。在第 26 周和第 52 周时，iGlarLixi 的安全性相似，记录到的有症状低血糖症和胃肠道事件发生率较低。
在 LixiLan-G 试验中，26 周随机治疗期结束时，iGlarLixi 的疗效和安全性在 26 周的扩展期内得以维持。
