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利拉鲁肽在接受多次胰岛素注射的西欧和南亚裔 2 型糖尿病患者中的血糖结局疗效:MAGNA VICTORIA 研究结果。

Efficacy of liraglutide on glycemic endpoints in people of Western European and South Asian descent with T2DM using multiple daily insulin injections: results of the MAGNA VICTORIA studies.

机构信息

Department of Radiology, Leiden University Medical Center, LUMC Postzone C2S, Albinusdreef 2, 2333 ZA, Leiden, The Netherlands.

Department of Medicine, Division of Endocrinology, and Einthoven Laboratory for Experimental Vascular Medicine, Leiden University Medical Center, Leiden, The Netherlands.

出版信息

Acta Diabetol. 2021 Apr;58(4):485-493. doi: 10.1007/s00592-020-01635-0. Epub 2021 Jan 5.

Abstract

AIMS

Data on the effect of liraglutide on glycemic endpoints in people with T2DM using multiple daily insulin injections (MDI) are scarce, especially in the context of ethnicity.

METHODS

This is a secondary analysis of the placebo-controlled randomized clinical "MAGNA VICTORIA" trials in Western European (WE) and South Asian (SA) people with T2DM. Participants had inadequate glycemic control despite using metformin and/or sulfonylurea derivatives and/or insulin. Participants were assigned to liraglutide (1.8 mg) or placebo for 6 months, in addition to standard care. The primary endpoint number of participants reaching target HbA1c was compared for liraglutide versus placebo in the complete dataset and MDI-treated participants using Chi-square test. Liraglutide's efficacy in WE and SA was compared using a generalized linear model.

RESULTS

Forty-five subjects were randomized to liraglutide and 51 to placebo. In each group, one participant did not complete the study. Liraglutide-treated patients reached target HbA1c more frequently: 23/45 (51%) vs 11/51 (22%), relative probability 2.4 (1.3-4.3), p = 0.002. Subgroup analysis in 43 MDI participants showed that the proportion reaching target HbA1c using liraglutide was significantly higher than in placebo: 9/22 (41%) vs 1/21 (5%), p = 0.005. There was no difference between WE and SA in terms of liraglutide efficacy (p = 0.18).

CONCLUSIONS

Liraglutide treatment resulted in increased chance of reaching target HbA1c as compared to placebo. Liraglutide efficacy was sustained in participants using MDI regimens and those of SA descent. Liraglutide should be considered for T2DM people with inadequate glycemic control despite MDI.

摘要

目的

关于使用多次胰岛素注射(MDI)的 2 型糖尿病(T2DM)患者使用利拉鲁肽对血糖终点影响的数据很少,特别是在种族方面。

方法

这是对西方欧洲(WE)和南亚(SA)T2DM 患者进行的安慰剂对照随机临床试验“MAGNA VICTORIA”的二次分析。尽管使用二甲双胍和/或磺酰脲衍生物和/或胰岛素,参与者的血糖控制仍不理想。参与者被分配接受利拉鲁肽(1.8 mg)或安慰剂,为期 6 个月,并接受标准治疗。使用卡方检验比较利拉鲁肽与安慰剂在完整数据集和 MDI 治疗参与者中的主要终点(达到目标 HbA1c 的参与者人数)。使用广义线性模型比较利拉鲁肽在 WE 和 SA 的疗效。

结果

45 名患者被随机分配接受利拉鲁肽治疗,51 名患者接受安慰剂治疗。在每组中,有一名参与者未完成研究。接受利拉鲁肽治疗的患者更频繁地达到目标 HbA1c:45 名患者中有 23 名(51%),51 名患者中有 11 名(22%),相对概率为 2.4(1.3-4.3),p=0.002。在 43 名 MDI 参与者的亚组分析中,使用利拉鲁肽达到目标 HbA1c 的比例明显高于安慰剂:22 名患者中有 9 名(41%),21 名患者中有 1 名(5%),p=0.005。利拉鲁肽疗效在 WE 和 SA 之间无差异(p=0.18)。

结论

与安慰剂相比,利拉鲁肽治疗使达到目标 HbA1c 的机会增加。在使用 MDI 方案和 SA 血统的参与者中,利拉鲁肽的疗效持续存在。对于血糖控制不理想的使用 MDI 的 T2DM 患者,应考虑使用利拉鲁肽。

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