胰岛素甘精/利西那肽固定比例复方（iGlarLixi 1:1）在口服抗糖尿病药物控制不佳的日本 2 型糖尿病患者中的疗效和安全性：一项随机、26 周、开放标签、多中心研究：LixiLan JP-O2 随机临床试验。
Efficacy and safety of insulin glargine/lixisenatide fixed-ratio combination (iGlarLixi 1:1) in Japanese patients with type 2 diabetes mellitus inadequately controlled on oral antidiabetic drugs: A randomized, 26-week, open-label, multicentre study: The LixiLan JP-O2 randomized clinical trial.
机构信息
Department of Endocrinology and Metabolism, Graduate School of Medicine, Yokohama City University, Yokohama, Japan.
Research & Development, Sanofi K.K., Tokyo, Japan.
出版信息
Diabetes Obes Metab. 2020 Sep;22 Suppl 4:14-23. doi: 10.1111/dom.14036.
AIMS
To assess efficacy and safety of 26-week treatment with insulin glargine/lixisenatide fixed-ratio combination (iGlarLixi) compared with insulin glargine U100 (iGlar) in Japanese patients with type 2 diabetes mellitus (T2DM) inadequately controlled on oral antidiabetic drugs (OADs).
MATERIALS AND METHODS
This phase 3, multicentre, open-label, 1:1 randomized, parallel-group study compared efficacy of iGlarLixi and iGlar in patients with T2DM, HbA1c of ≥7.5% to ≤9.5% and fasting plasma glucose ≤10.0 mmol/L (180 mg/dL). The primary endpoint was change in HbA1c from baseline to week 26.
RESULTS
Patients were randomized to iGlarLixi (n = 260) or iGlar (n = 261) (mean age 59.7 years, baseline BMI 26.04 kg/m , and HbA1c 8.04% [64.4 mmol/mol]). HbA1c reduction was significantly greater with iGlarLixi (-1.40% [-15.3 mmol/mol]) than with iGlar (-0.76% [-8.3 mmol/mol]). Significantly more iGlarLixi patients reached HbA1c <7% at week 26 (71.5% vs 38.5%, P < .0001), with significantly lower weight gain (LS mean difference -1.06 kg, P < .0001). Documented symptomatic hypoglycemia (plasma glucose ≤3.9 mmol/L [70 mg/dL]) was recorded in 14.2% of patients with iGlarLixi and 12.3% with iGlar. No severe hypoglycemia was reported in either group. Other than the expected gastrointestinal issues associated with glucagon-like peptide 1 receptor agonists, we found no major difference in the incidence of TEAEs.
CONCLUSIONS
HbA1c reduction was significantly greater with iGlarLixi than with iGlar; significantly more patients achieved HbA1c <7%, with no additional risk of hypoglycemia and without weight gain. iGlarLixi (1:1) provided an effective treatment option for Japanese patients with T2DM inadequately controlled on OADs. Clinical Trial Number: NCT02752828.
目的
评估 26 周胰岛素 glargine/lixisenatide 固定比例组合（iGlarLixi）治疗与胰岛素 glargine U100（iGlar）治疗在口服抗糖尿病药物（OAD）控制不佳的日本 2 型糖尿病（T2DM）患者中的疗效和安全性。
材料和方法
这是一项 3 期、多中心、开放标签、1:1 随机、平行组研究，比较了 iGlarLixi 和 iGlar 在 T2DM 患者中的疗效，这些患者的 HbA1c 为≥7.5%至≤9.5%，空腹血浆葡萄糖≤10.0mmol/L（180mg/dL）。主要终点是从基线到第 26 周时 HbA1c 的变化。
结果
患者被随机分配到 iGlarLixi（n=260）或 iGlar（n=261）组（平均年龄 59.7 岁，基线 BMI 26.04kg/m，HbA1c 8.04%[64.4mmol/mol]）。iGlarLixi（-1.40%[-15.3mmol/mol]）治疗组的 HbA1c 降低幅度明显大于 iGlar（-0.76%[-8.3mmol/mol]）治疗组。在第 26 周时，更多的 iGlarLixi 患者达到 HbA1c<7%（71.5%比 38.5%，P<.0001），体重增加明显减少（LS 均值差异-1.06kg，P<.0001）。记录到 14.2%的 iGlarLixi 患者和 12.3%的 iGlar 患者发生有症状的低血糖（血浆葡萄糖≤3.9mmol/L[70mg/dL]）。两组均未报告严重低血糖。除了与胰高血糖素样肽 1 受体激动剂相关的预期胃肠道问题外，我们未发现不良事件发生率有较大差异。
结论
与 iGlar 相比，iGlarLixi 可显著降低 HbA1c；更多的患者达到 HbA1c<7%，且低血糖风险无增加，体重无增加。iGlarLixi（1:1）为 OAD 控制不佳的日本 T2DM 患者提供了一种有效的治疗选择。临床试验编号：NCT02752828。
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