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利西拉来/甘精胰岛素固定比例复方治疗 2 型糖尿病患者的血糖达标情况:LixiLan-O 和 LixiLan-L 试验的事后分析。

Glycaemic target attainment in people with Type 2 diabetes treated with insulin glargine/lixisenatide fixed-ratio combination: a post hoc analysis of the LixiLan-O and LixiLan-L trials.

机构信息

Touchstone Diabetes Center, Department of Internal Medicine, The University of Texas Southwestern Medical Center, Dallas, TX, USA.

University of Nebraska Medical Center, Omaha, NE, USA.

出版信息

Diabet Med. 2020 Feb;37(2):256-266. doi: 10.1111/dme.14094. Epub 2019 Nov 26.

Abstract

AIMS

Both fasting (FPG) and postprandial plasma glucose (PPG) contribute to HbA levels. We investigated the relationship between achievement of American Diabetes Association (ADA) and American Association of Clinical Endocrinologists (AACE) recommended FPG and/or PPG targets and glycaemic efficacy outcomes in two trials.

METHODS

In this post hoc analysis, data from participants with Type 2 diabetes in the phase 3 LixiLan-O (NCT02058147) and LixiLan-L (NCT02058160) trials were evaluated to compare the relationship between achievement of society-recommended FPG and/or PPG targets and efficacy (HbA change, HbA goal attainment, weight change) and safety outcomes in the treatment groups.

RESULTS

Across treatment arms, iGlarLixi achieved the highest proportion of participants meeting both ADA- and AACE-recommended FPG and PPG targets at study end in both trials. A higher proportion of participants in the iGlarLixi (fixed-ratio combination of insulin glargine and lixisenatide) vs. insulin glargine alone or lixisenatide alone treatment arms achieved HbA goals (P < 0.001 for overall comparisons), irrespective of ADA- or AACE-defined targets. Hypoglycaemia rates [any, documented symptomatic (plasma glucose ≤ 3.9 mmol/l), and clinically important (plasma glucose < 3.0 mmol/l)] were low across all groups. Participants treated with iGlarLixi tended to show weight loss or less weight gain compared with participants receiving insulin glargine alone. No differences were observed in average daily basal insulin dose at week 30 between the two treatment arms or across the different FPG and PPG target groups.

CONCLUSION

Insulin glargine and lixisenatide as a fixed-ratio combination resulted in more participants reaching both FPG and PPG targets, leading to better HbA target attainment.

摘要

目的

空腹血糖(FPG)和餐后血糖(PPG)均与 HbA 水平相关。我们研究了在两项试验中,达到美国糖尿病协会(ADA)和美国临床内分泌医师协会(AACE)推荐的 FPG 和/或 PPG 目标与血糖疗效结果之间的关系。

方法

在这项事后分析中,我们评估了 LixiLan-O(NCT02058147)和 LixiLan-L(NCT02058160)三期临床试验中 2 型糖尿病患者的数据,以比较在不同治疗组中,达到社会推荐的 FPG 和/或 PPG 目标与疗效(HbA 变化、HbA 达标、体重变化)和安全性结果之间的关系。

结果

在所有治疗组中,在两项试验中,iGlarLixi 在研究结束时达到 ADA 和 AACE 推荐的 FPG 和 PPG 目标的患者比例最高。与胰岛素甘精单独或利西那肽单独治疗组相比,iGlarLixi(胰岛素甘精和利西那肽的固定比例组合)治疗组中达到 HbA 目标的患者比例更高(整体比较,P<0.001),无论采用 ADA 还是 AACE 定义的目标。所有组的低血糖发生率[任何、有记录的症状性(血糖≤3.9mmol/L)和临床重要性(血糖<3.0mmol/L)]均较低。与接受胰岛素甘精单独治疗的患者相比,接受 iGlarLixi 治疗的患者体重减轻或体重增加较少。在第 30 周时,两组之间或不同 FPG 和 PPG 目标组之间的平均每日基础胰岛素剂量没有差异。

结论

胰岛素甘精和利西那肽的固定比例组合使更多的患者达到了 FPG 和 PPG 目标,从而更好地实现了 HbA 目标。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/8976/7003844/36e2a5909d3b/DME-37-256-g001.jpg

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