Department of Internal Medicine, Pusan National University Hospital, Pusan National University School of Medicine, Busan, South Korea.
Biomedical Research Institute, Pusan National University Hospital, Busan, South Korea.
Diabetes Obes Metab. 2022 Sep;24(9):1800-1809. doi: 10.1111/dom.14766. Epub 2022 Jun 9.
To compare the efficacy and safety of adding low-dose lobeglitazone (0.25 mg/day) or standard-dose lobeglitazone (0.5 mg/day) to patients with type 2 diabetes mellitus (T2DM) with inadequate glucose control on metformin and dipeptidyl peptidase (DPP4) inhibitor therapy.
In this phase 4, multicentre, double-blind, randomized controlled, non-inferiority trial, patients with T2DM insufficiently controlled by metformin and DPP4 inhibitor combination therapy were randomized to receive either low-dose or standard-dose lobeglitazone. The primary endpoint was non-inferiority of low-dose lobeglitazone in terms of glycaemic control, expressed as the difference in mean glycated haemoglobin levels at week 24 relative to baseline values and compared with standard-dose lobeglitazone, using 0.5% non-inferiority margin.
At week 24, the mean glycated haemoglobin levels were 6.87 ± 0.54% and 6.68 ± 0.46% in low-dose and standard-dose lobeglitazone groups, respectively (p = .031). The between-group difference was 0.18% (95% confidence interval 0.017-0.345), showing non-inferiority of the low-dose lobeglitazone. Mean body weight changes were significantly greater in the standard-dose group (1.36 ± 2.23 kg) than in the low-dose group (0.50 ± 1.85 kg) at week 24. The changes in HOMA-IR, lipid profile and liver enzyme levels showed no significant difference between the groups. Overall treatment-emergent adverse events (including weight gain, oedema and hypoglycaemia) occurred more frequently in the standard-dose group.
Adding low-dose lobeglitazone to metformin and DPP4 inhibitor combination resulted in a non-inferior glucose-lowering outcome and fewer adverse events compared with standard-dose lobeglitazone. Therefore, low-dose lobeglitazone might be one option for individualized strategy in patients with T2DM.
比较在二甲双胍和二肽基肽酶（DPP4）抑制剂联合治疗血糖控制不佳的 2 型糖尿病（T2DM）患者中添加低剂量罗格列酮（0.25mg/天）或标准剂量罗格列酮（0.5mg/天）的疗效和安全性。
在这项 4 期、多中心、双盲、随机、对照、非劣效性试验中，二甲双胍和 DPP4 抑制剂联合治疗血糖控制仍不理想的 T2DM 患者被随机分为接受低剂量或标准剂量罗格列酮治疗。主要终点是低剂量罗格列酮在血糖控制方面不劣于标准剂量罗格列酮，用 0.5%非劣效性边界，以 24 周时相对于基线值的平均糖化血红蛋白水平的差异表示。
在 24 周时，低剂量和标准剂量罗格列酮组的平均糖化血红蛋白水平分别为 6.87±0.54%和 6.68±0.46%（p=0.031）。组间差异为 0.18%（95%置信区间 0.017-0.345），表明低剂量罗格列酮具有非劣效性。在 24 周时，标准剂量组的体重变化显著大于低剂量组（1.36±2.23kg），而低剂量组的体重变化显著大于低剂量组（0.50±1.85kg）。两组间 HOMA-IR、血脂谱和肝酶水平的变化无显著差异。标准剂量组更常发生整体治疗出现的不良事件（包括体重增加、水肿和低血糖）。
与标准剂量罗格列酮相比，在二甲双胍和 DPP4 抑制剂联合治疗的基础上加用低剂量罗格列酮可达到相似的降糖效果，且不良事件更少。因此，低剂量罗格列酮可能是 T2DM 患者个体化治疗策略的一种选择。
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