糖尿病创新药iGlarLixi中国III期临床试验达到主要有效性终点

2021-10-09 梅斯医学 梅斯医学

数据喜人

2021930日,赛诺菲中国在第57届欧洲糖尿病研究协会(EASD)年会宣布,该公司在中国开展的基础胰岛素与GLP-1RA的固定比例复方制剂SOLIQUA® (iGlarLixi)*III期临床研究LixiLan-L中国研究达到了主要有效性终点和次要终点。

LixiLan-L中国研究是一项随机、开放标签、阳性对照、平行分组、持续30周治疗的临床试验,旨在评估iGlarLixi的疗效和安全性。此项试验共入组426名中国成年受试者,均为确诊2型糖尿病超过一年且经基础胰岛素(联合或不联合口服降糖药)治疗后血糖控制不佳的患者。

LixiLan-L中国研究结果显示,相较基础胰岛素治疗组,接受iGlarLixi治疗的患者在降低糖化血红蛋白(HbA1c)方面达到了预设的主要疗效终点。在治疗30周时,iGlarLixi组患者HbA1c平均值达到6.7%,而基础胰岛素组为7.4%。其中,HbA1c达标(HbA1c<7%)患者在iGlarLixi组的比例为63%,基础胰岛素组为30%。此外,该试验结果也达到了预设次要终点,iGlarLixi组在餐后血糖控制、体重控制以及低血糖发生率等方面都优于基础胰岛素组。

LixiLan-L 中国研究主要研究者北京大学第一医院内分泌科郭晓蕙教授表示:此次临床试验结果证实了在基础胰岛素联合或不联合最多两个口服降糖药治疗后血糖仍控制不佳的患者中,iGlarLixi相较于基础胰岛素的有效性和安全性。我们很期待未来iGlarLixi可以为广大中国糖尿病患者提供一种全新的降糖选择。

赛诺菲大中华区普药医学部负责人谷成明博士表示:我们非常欣喜此次临床试验的研究结果,该研究结果充分证明了iGlarLixi在中国成年2型糖尿病患者中卓越的降糖疗效和安全性,我们希望未来通过iGlarLixi的治疗能够帮助广大中国糖尿病患者实现更好的血糖管理目标,进一步助力血糖的优质达标。

*SOLIQUA®(iGlarLixi)尚未在中国获批

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    2021-12-05 juliusluan78
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    2021-10-11 heli0118
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