Glycaemic control, body weight, and safety of tirzepatide versus dulaglutide by baseline glycated haemoglobin level in Japanese patients with type 2 diabetes: A subgroup analysis of the SURPASS J-mono study

IF 5.4 2区医学 Q1 ENDOCRINOLOGY & METABOLISM Diabetes, Obesity & Metabolism Pub Date : 2023-10-04 DOI:10.1111/dom.15296

Takeshi Osonoi MD, Tomonori Oura MSc, Tetsuaki Hirase MD

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Abstract

Aim

To evaluate glycaemic control, body weight, and safety outcomes following treatment with tirzepatide or dulaglutide in patients with type 2 diabetes (T2D) with a baseline haemoglobin (HbA1c) level of ≤8.5% (≤69 mmol/mol) versus >8.5% (>69 mmol/mol).

Materials and Methods

SURPASS J-mono was a 52-week, multicentre, randomized, double-blind, parallel, active-controlled, phase 3 study conducted in Japan. In this exploratory subgroup analysis of SURPASS J-mono, we examined mean change in HbA1c and body weight and the incidence of adverse events (AEs) in patients with a baseline HbA1c of ≤8.5% versus >8.5% after treatment with tirzepatide (5, 10 or 15 mg) or dulaglutide 0.75 mg.

Results

Of 636 randomized participants, 203 had a baseline HbA1c of >8.5% and 433 had a baseline HbA1c of ≤8.5% (range ≥7.0% to ≤10.0%). Both subgroups showed significantly greater reductions in HbA1c and body weight with any-dose tirzepatide versus dulaglutide 0.75 mg, with greater HbA1c reductions observed in patients with a baseline HbA1c of >8.5% treated with tirzepatide (least squares mean [LSM] differences of −3.13% to −3.86%) or dulaglutide (LSM −1.81%) compared with patients with a baseline HbA1c of ≤8.5% (LSM −2.00% to −2.32%) or dulaglutide (LSM −1.05%; treatment-by-baseline HbA1c subgroup interaction P ≤ 0.001). For the tirzepatide treatment arms, LSM change from baseline in body weight ranged from −6.7 to −10.7 kg for the baseline HbA1c ≤8.5% subgroup and from −4.0 to −10.6 kg for the baseline HbA1c >8.5% subgroup, compared with −0.6 kg and −0.4 kg, respectively, for the dulaglutide arm. The incidence of hypoglycaemia was low, with no substantial difference in hypoglycaemia or treatment-emergent AEs between subgroups.

Conclusions

Regardless of baseline HbA1c (≤8.5% or >8.5%), tirzepatide at doses of 5, 10 and 15 mg is effective in Japanese patients with T2D compared with dulaglutide 0.75 mg in terms of glycaemic control and body weight reduction, with an adequate safety profile consistent with previous reports.

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日本2型糖尿病患者的血糖控制、体重和通过基线糖化血红蛋白水平比较替西帕肽与杜拉鲁肽的安全性：SURPASS J-mono研究的亚组分析。

目的：评估基线血红蛋白（HbA1c）水平≤8.5%（≤69 mmol/mol）和>8.5%（>69 mmol/mmol）的2型糖尿病（T2D）患者接受替西帕肽或杜拉鲁肽治疗后的血糖控制、体重和安全性结果。材料和方法：SURPASS J-mono是一项在日本进行的为期52周的多中心、随机、双盲、平行、主动对照的3期研究。在SURPASS J-mono的这项探索性亚组分析中，我们检测了基线HbA1c≤8.5%的患者的HbA1c和体重的平均变化以及不良事件（AE）的发生率，而接受替西帕肽治疗后（5、10或15 mg）或杜拉鲁肽0.75 结果：在636名随机参与者中，203人的基线HbA1c>8.5%，433人的基线血红蛋白A1c≤8.5%（范围≥7.0%至≤10.0%）。与杜拉鲁肽0.75相比，两个亚组的任何剂量的替西帕肽的HbA1c和体重均显著降低 mg，与基线HbA1c≤8.5%（LSM-2.00%至-2.32%）或杜拉鲁肽（LSM-1.05%）的患者相比，用替西帕肽（最小二乘平均[LSM]差异为-3.13%至-3.86%）或杜拉鲁肽（LSM-1.81%）治疗的基线HbA1c>8.5%的患者的HbA1c降低幅度更大；通过基线HbA1c-亚组相互作用P ≤ 0.001）。对于替西帕肽治疗组，LSM与基线相比的体重变化范围为-6.7至-10.7 基线HbA1c≤8.5%亚组的kg，从-4.0到-10.6 基线HbA1c>8.5%亚组的kg，相比之下为-0.6 kg和-0.4 杜拉鲁肽组分别为kg。低血糖的发生率较低，各亚组之间的低血糖或治疗引发的不良事件没有显著差异。结论：无论基线HbA1c（≤8.5%或>8.5%）如何，替西帕肽的剂量分别为5、10和15 mg与0.75杜拉鲁肽相比对日本T2D患者有效 mg在血糖控制和体重减轻方面，具有与先前报告一致的足够安全性。

本文章由计算机程序翻译，如有差异，请以英文原文为准。

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来源期刊

Diabetes, Obesity & Metabolism 医学-内分泌学与代谢

CiteScore

10.90

自引率

6.90%

发文量

319

审稿时长

3-8 weeks

期刊介绍： Diabetes, Obesity and Metabolism is primarily a journal of clinical and experimental pharmacology and therapeutics covering the interrelated areas of diabetes, obesity and metabolism. The journal prioritises high-quality original research that reports on the effects of new or existing therapies, including dietary, exercise and lifestyle (non-pharmacological) interventions, in any aspect of metabolic and endocrine disease, either in humans or animal and cellular systems. ‘Metabolism’ may relate to lipids, bone and drug metabolism, or broader aspects of endocrine dysfunction. Preclinical pharmacology, pharmacokinetic studies, meta-analyses and those addressing drug safety and tolerability are also highly suitable for publication in this journal. Original research may be published as a main paper or as a research letter.