The efficacy and safety of beinaglutide alone or in combination with insulin glargine in Chinese patients with type 2 diabetes mellitus who are inadequately controlled with oral antihyperglycemic therapy: A multicenter, open-label, randomized trial

IF 3 2区医学 Q2 ENDOCRINOLOGY & METABOLISM

Journal of Diabetes Pub Date : 2023-10-20 DOI:10.1111/1753-0407.13483

Xiangyang Liu, Wenjuan Yang, Jianrong Liu, Xinxi Huang, Yujie Fang, Jie Ming, Jingbo Lai, Jianfang Fu, Qiuhe Ji, Li Wang

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引用次数: 0

Abstract

Background

To compare glycemic control in Chinese patients with type 2 diabetes mellitus (T2DM) whose blood glucose levels were inadequately controlled with oral antidiabetic drugs after beinaglutide alone or combined with insulin glargine (IGlar).

Methods

In this 16-week multicenter, randomized clinical trial, 68 participants randomly received beinaglutide or IGlar for 8 weeks, then the two drugs in combination for 8 weeks. The primary outcomes were the proportion of individuals achieving their glycemic target and the change in glucose variability as measured with a continuous glucose monitoring system from baseline to 8 and 16 weeks.

Results

Both the beinaglutide and IGlar groups showed increased proportions achieving their glycemic target at 8 weeks, and the combination augmented the proportion reaching the glycated hemoglobin target from 25.42% at 8 weeks to 40.68% at 16 weeks. The beinaglutide group showed a significant reduction in body weight, body mass index, waist circumference, and systolic blood pressure. Beinaglutide elevated high-density lipoprotein cholesterol by 0.08 mmol/L (95% confidence interval [CI], 0.00–0.16), and diminished low-density lipoprotein cholesterol by 0.21 mmol/L (95% CI, 0.05–0.48), whereas IGlar showed no effect. Though IGlar was more efficient in lowering fasting plasma glucose than beinaglutide at comparable efficacies (to −1.57 mmol/L [95% CI, −2.60 to −0.54]), this difference was abolished in patients whose fasting C-peptide was ≥0.9 ng/mL.

Conclusion

Beinaglutide exhibited a favorable hypoglycemic effect on patients with T2DM, and in combination with IGlar, glucose level was further decreased. Low fasting C-peptide in patients may reduce the glycemic response to beinaglutide therapy. We recommend that C-peptide levels be evaluated when using or switching to the novel glucagon-like peptide-1 receptor agonists beinaglutide.

Trial Registration

ClinicalTrials.gov: NCT03829891.

Abstract Image

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贝那鲁肽单独或联合甘精胰岛素治疗口服抗高血糖治疗效果不佳的中国2型糖尿病患者的疗效和安全性：一项多中心、开放标签、随机试验。

背景：比较中国2型糖尿病（T2DM）患者在单用贝那鲁肽或联合甘精胰岛素（IGlar）治疗后血糖水平未得到充分控制的情况下，口服抗糖尿病药物的血糖控制情况周，然后两种药物联合使用8 周。主要结果是从基线到8和16，用连续血糖监测系统测量的实现血糖目标的个体比例和血糖变异性的变化周。结果：贝那鲁肽组和IGlar组均显示出在8时达到血糖目标的比例增加周，联合用药使达到糖化血红蛋白目标的比例从8岁时的25.42%增加周至16岁时的40.68% 周。贝那鲁肽组的体重、体重指数、腰围和收缩压显著降低。贝那鲁肽使高密度脂蛋白胆固醇升高0.08 mmol/L（95%置信区间[CI]，0.00-0.16），低密度脂蛋白胆固醇降低0.21 mmol/L（95%可信区间，0.05-0.48），而IGlar则无影响。尽管IGlar在降低空腹血糖方面比贝那鲁肽更有效，但其疗效相当（-1.57 mmol/L[95%CI，-2.60至-0.54]），在空腹C肽≥0.9的患者中，这种差异被消除结论：贝那鲁肽对2型糖尿病患者具有良好的降血糖作用，与IGlar联合应用可进一步降低血糖水平。患者空腹C肽水平较低可能会降低贝那鲁肽治疗的血糖反应。我们建议在使用或改用新型胰高血糖素样肽-1受体激动剂贝那鲁肽时评估C肽水平。试验注册：ClinicalTrials.gov:NCT03829891。

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来源期刊

Journal of Diabetes ENDOCRINOLOGY & METABOLISM-

CiteScore

6.50

自引率

2.20%

发文量

审稿时长

>12 weeks

期刊介绍： Journal of Diabetes (JDB) devotes itself to diabetes research, therapeutics, and education. It aims to involve researchers and practitioners in a dialogue between East and West via all aspects of epidemiology, etiology, pathogenesis, management, complications and prevention of diabetes, including the molecular, biochemical, and physiological aspects of diabetes. The Editorial team is international with a unique mix of Asian and Western participation. The Editors welcome submissions in form of original research articles, images, novel case reports and correspondence, and will solicit reviews, point-counterpoint, commentaries, editorials, news highlights, and educational content.