Department of Metabolism and Endocrinology, Juntendo University Graduate School of Medicine, Tokyo, Japan
Research & Development, Sanofi K.K., Tokyo, Japan.
Diabetes Care. 2020 Jun;43(6):1249-1257. doi: 10.2337/dc19-2452. Epub 2020 Apr 15.
To assess the efficacy and safety of a 1:1 fixed-ratio combination of insulin glargine and lixisenatide (iGlarLixi) versus lixisenatide (Lixi) in insulin-naive Japanese patients with type 2 diabetes mellitus (T2DM) inadequately controlled on oral antidiabetic drugs (OADs).
In this phase 3, open-label, multicenter trial, 321 patients with HbA≥7.5 to ≤10.0% (58-86 mmol/mol) and fasting plasma glucose (FPG) ≤13.8 mmol/L (250 mg/dL) were randomized 1:1 to iGlarLixi or Lixi for 52 weeks. The primary end point was change in HbA at week 26.
Change in HbA from baseline to week 26 was significantly greater with iGlarLixi (-1.58% [-17.3 mmol/mol]) than with Lixi (-0.51% [-5.6 mmol/mol]), confirming the superiority of iGlarLixi (least squares [LS] mean difference -1.07% [-11.7 mmol/mol], < 0.0001). At week 26, significantly greater proportions of patients treated with iGlarLixi reached HbA <7% (53 mmol/mol) (65.2% vs. 19.4%; < 0.0001), and FPG reductions were greater with iGlarLixi than Lixi (LS mean difference -2.29 mmol/L [-41.23 mg/dL], < 0.0001). Incidence of documented symptomatic hypoglycemia (≤3.9 mmol/L [70 mg/dL]) was higher with iGlarLixi (13.0% vs. 2.5%) through week 26, with no severe hypoglycemic events in either group. Incidence of gastrointestinal events through week 52 was lower with iGlarLixi (36.0% vs. 50.0%), and rates of treatment-emergent adverse events were similar.
This phase 3 study demonstrated superior glycemic control and fewer gastrointestinal adverse events with iGlarLixi than with Lixi, which may support it as a new treatment option for Japanese patients with T2DM that is inadequately controlled with OADs.
评估胰岛素甘精和利西那肽（iGlarLixi） 1:1 固定比例组合与利西那肽（Lixi）相比，在口服抗糖尿病药物（OADs）控制不佳的日本 2 型糖尿病（T2DM）患者中的疗效和安全性。
在这项 3 期、开放标签、多中心试验中，321 名糖化血红蛋白（HbA）≥7.5 至≤10.0%（58-86 mmol/mol）且空腹血糖（FPG）≤13.8 mmol/L（250 mg/dL）的患者按 1:1 随机分为 iGlarLixi 或 Lixi 组，治疗 52 周。主要终点为治疗 26 周时 HbA 的变化。
与 Lixi 相比（-0.51%[-5.6 mmol/mol]），iGlarLixi（-1.58%[-17.3 mmol/mol]）使 HbA 自基线的变化显著更大，证实了 iGlarLixi 的优越性（最小二乘[LS]均值差异-1.07%[-11.7 mmol/mol]，<0.0001）。在第 26 周时，接受 iGlarLixi 治疗的患者中有更大比例达到 HbA<7%（53 mmol/mol）（65.2% vs. 19.4%；<0.0001），并且 iGlarLixi 的 FPG 降低幅度大于 Lixi（LS 均值差异-2.29 mmol/L[-41.23 mg/dL]，<0.0001）。通过第 26 周，iGlarLixi 治疗组的有记录的症状性低血糖（≤3.9 mmol/L[70 mg/dL]）发生率较高（13.0% vs. 2.5%），两组均无严重低血糖事件。通过第 52 周时，iGlarLixi 治疗组胃肠道不良事件的发生率较低（36.0% vs. 50.0%），并且治疗期间出现的不良事件的发生率相似。
与 Lixi 相比，这项 3 期研究表明 iGlarLixi 具有更好的血糖控制效果和较少的胃肠道不良事件，这可能使其成为一种新的治疗选择，用于治疗 OADs 控制不佳的日本 T2DM 患者。
