Lilavati Hospital and Research Centre, Mumbai, Maharashtra, India.
Manager, Department of Global Medical Affairs (IF), Glenmark Pharmaceuticals Limited, Mumbai, Maharashtra, India.
J Assoc Physicians India. 2024 Jan;72(1):32-42. doi: 10.59556/japi.71.0445.
The efficacy and safety of lobeglitazone sulfate has been reported only in the Korean population, and no study has been conducted in India.
In this 16-week randomized, double-blind, and multicenter study, the efficacy and safety of lobeglitazone sulfate 0.5 mg were evaluated with pioglitazone 15 mg. Type 2 diabetes mellitus (T2DM) patients with ≥7.5% glycated hemoglobin (HbA1c) ≤10.5% and on stable metformin dose were assigned to both treatment arms. The primary outcome was a mean change in HbA1c. Safety assessments included adverse events (AE), home-based glucose monitoring, vital parameters, electrocardiogram (ECG), and laboratory assessments.
A total of 328 subjects were randomized equally in two groups. A statistically significant reduction in HbA1c at week 16 in the lobeglitazone group with the least square (LS) mean change: 1.01 [standard error (SE): 0.09] ( < 0.0001) was seen. The LS mean difference between the two groups was 0.05 (SE: 0.12) [95% confidence interval (CI): -0.18, 0.27], which was statistically significant ( = 0.0013). Statistically significant reductions were also observed in fasting and postprandial glucose. Treatment-emergent Aes (TEAE) were comparable between both groups.
Lobeglitazone 0.5 mg once daily was found to be efficacious and safe in the treatment of T2DM in the Indian population. Lobeglitazone significantly improved glycemic parameters and was noninferior to pioglitazone; hence, it could be a promising insulin sensitizer in T2DM management in India.
硫酸罗格列酮的疗效和安全性仅在韩国人群中得到报道，而在印度尚未进行研究。
在这项为期 16 周的随机、双盲、多中心研究中，评估了硫酸罗格列酮 0.5mg 与吡格列酮 15mg 的疗效和安全性。将糖化血红蛋白（HbA1c）≥7.5%且稳定使用二甲双胍的 2 型糖尿病（T2DM）患者分配到两个治疗组。主要结局是 HbA1c 的平均变化。安全性评估包括不良事件（AE）、家庭血糖监测、生命体征、心电图（ECG）和实验室评估。
共有 328 名受试者被平均随机分配到两组。硫酸罗格列酮组在第 16 周时 HbA1c 显著下降，最小二乘（LS）均值变化为 1.01[标准误差（SE）：0.09]（<0.0001）。两组间 LS 均值差异为 0.05（SE：0.12）[95%置信区间（CI）：-0.18，0.27]，具有统计学意义（=0.0013）。空腹和餐后血糖也有显著降低。两组间治疗出现的不良事件（TEAE）相当。
硫酸罗格列酮 0.5mg 每日一次在印度人群中治疗 T2DM 是有效和安全的。硫酸罗格列酮显著改善了血糖参数，与吡格列酮相当，因此在印度 T2DM 管理中可能是一种有前途的胰岛素增敏剂。
