Department of Hematology, Endocrinology and Metabolism, Faculty of Medicine, Niigata University, Niigata City, Japan.
Japan Drug Development and Medical Affairs, Eli Lilly Japan K.K., Kobe, Japan.
Diabetes Obes Metab. 2024 Nov;26(11):5304-5311. doi: 10.1111/dom.15887. Epub 2024 Aug 27.
Normoglycaemia was achieved in a significant proportion of Japanese participants with type 2 diabetes in two phase 3 studies of tirzepatide. This post hoc exploratory analysis aimed to identify predictive factors associated with normoglycaemia achievement.
SURPASS J-mono and SURPASS J-combo study data were pooled for this analysis. Characteristics of participants in whom normoglycaemia [glycated haemoglobin (HbA1c) <5.7%] was achieved were summarized. Logistic regression analyses were performed with HbA1c <5.7% achievement as the target variable.
Of 912 participants, normoglycaemia was achieved in 553 (60.6%) following 52 weeks of tirzepatide treatment. Overall, the mean (SD) age was 56.7 (10.6) years and mean diabetes duration was 7.7 (6.0) years, and 76% of participants were men. Mean (SD) change from baseline in HbA1c and bodyweight was -2.87% (0.95) versus -2.47% (1.1) and -10.30 (5.8) kg versus -3.75 (4.3) kg for participants in whom normoglycaemia was and was not reached, respectively. Multivariate regression analyses showed that lower baseline body mass index, shorter disease duration and lower baseline HbA1c were significantly associated with higher rates of normoglycaemia achievement (p = 0.009, p = 0.008, p < 0.001, respectively) as was a tirzepatide dose of 10 or 15 mg compared with 5 mg (p < 0.001). The highest percentage of participants in whom normoglycaemia (94%) was achieved were those with lower baseline HbA1c (<8%) and the greatest weight reduction (≥15%).
Baseline HbA1c and body mass index, disease duration and the tirzepatide treatment group were shown to be predictive factors for achieving normoglycaemia. A lower baseline HbA1c was most strongly associated with normoglycaemia achievement.
在两项关于替西帕肽的 3 期研究中，相当一部分 2 型糖尿病日本患者达到了血糖正常化。本事后探索性分析旨在确定与血糖正常化达标相关的预测因素。
对该分析汇总了 SURPASS J-mono 和 SURPASS J-combo 研究的数据。总结了血糖正常化（糖化血红蛋白（HbA1c）<5.7%）患者的特征。以 HbA1c<5.7%达标为目标变量进行 logistic 回归分析。
在 912 名参与者中，912 名参与者中有 553 名（60.6%）在接受替西帕肽治疗 52 周后达到血糖正常化。总体而言，平均（SD）年龄为 56.7（10.6）岁，平均糖尿病病程为 7.7（6.0）年，76%的参与者为男性。与未达到血糖正常化的参与者相比，基线时 HbA1c 和体重的平均（SD）变化分别为-2.87%（0.95）与-2.47%（1.1）和-10.30（5.8）kg 与-3.75（4.3）kg。多变量回归分析显示，较低的基线体重指数、较短的病程和较低的基线 HbA1c 与较高的血糖正常化达标率显著相关（p=0.009，p=0.008，p<0.001），而与 5mg 相比，替西帕肽 10mg 或 15mg 的剂量也与较高的血糖正常化达标率相关（p<0.001）。血糖正常化（94%）达标率最高的参与者是那些基线 HbA1c 较低（<8%）和体重减轻最大（≥15%）的参与者。
基线 HbA1c 和体重指数、病程以及替西帕肽治疗组被证明是血糖正常化的预测因素。较低的基线 HbA1c 与血糖正常化达标最密切相关。
