Kim Sin Gon, Kim Doo Man, Woo Jeong-Taek, Jang Hak Chul, Chung Choon Hee, Ko Kyung Soo, Park Jeong Hyun, Park Yong Soo, Kim Sang Jin, Choi Dong Seop
Department of Internal Medicine, Korea University Anam Hospital, Seoul, Korea.
Department of Internal Medicine, Hallym University Kangdong Sacred Heart Hospital, Seoul, Korea.
PLoS One. 2014 Apr 15;9(4):e92843. doi: 10.1371/journal.pone.0092843. eCollection 2014.
The aim of this study was to assess the glucose-lowering and lipid-modifying effects, and safety profile of lobeglitazone, a novel peroxisome proliferator-activated receptor- γ agonist, compared to placebo as a monotherapy in patients with type 2 diabetes.
In this 24-week, multicenter, randomized, double-blind, parallel-group, placebo controlled study, 173 patients were randomly assigned (a 2∶1 ratio) to lobeglitazone 0.5 mg (n=115) or matching placebo (n=58) orally once daily. The primary endpoint was the change in glycated hemoglobin (HbA1c) from baseline to the end of treatment. The secondary endpoints included various glycemic parameters, lipid parameters and safety profile (ClinicalTrials.gov number NCT01001611).
At 24 weeks, a significant reduction in HbA1c was observed with lobeglitazone versus placebo (-0.44% vs 0.16%, mean difference -0.6%, p<0.0001). The goal of HbA1c <7% was achieved significantly more in the lobeglitazone group compared to the placebo group (44% vs 12%, p<0.0001). Markers of insulin resistance were also improved in the lobeglitazone group. In addition, lobeglitazone treatment significantly improved triglycerides, high density lipoprotein cholesterol, small dense low density lipoprotein cholesterol, free fatty acid, and apolipoprotein-B/CIII compared to placebo (p<0.01, respectively). More weight gain was observed in the lobeglitazone group than the placebo group (0.89 kg vs - 0.63 kg, mean difference 1.52 kg, p<0.0001). The safety profile was comparable between the two groups and lobeglitazone was well tolerated.
Lobeglitazone 0.5 mg showed a favorable balance in the efficacy and safety profile. The results support a potential role of lobeglitazone in treating type 2 diabetes.
Clinicaltrials.gov NCT01001611.
本研究旨在评估新型过氧化物酶体增殖物激活受体γ激动剂罗格列酮作为单一疗法治疗2型糖尿病患者时的降糖、调脂作用及安全性，与安慰剂进行对比。
在这项为期24周的多中心、随机、双盲、平行组、安慰剂对照研究中，173例患者按2∶1比例随机分配，分别口服罗格列酮0.5毫克（n = 115）或匹配的安慰剂（n = 58），每日一次。主要终点是糖化血红蛋白（HbA1c）从基线到治疗结束的变化。次要终点包括各种血糖参数、血脂参数及安全性（ClinicalTrials.gov编号NCT01001611）。
24周时，与安慰剂相比，罗格列酮组HbA1c显著降低（-0.44% 对0.16%，平均差值 -0.6%，p < 0.0001）。与安慰剂组相比，罗格列酮组显著更多患者实现了HbA1c < 7%的目标（44% 对12%，p < 0.0001）。罗格列酮组胰岛素抵抗指标也得到改善。此外，与安慰剂相比，罗格列酮治疗显著改善了甘油三酯、高密度脂蛋白胆固醇、小而密低密度脂蛋白胆固醇、游离脂肪酸及载脂蛋白B/CIII（p均 < 0.01）。罗格列酮组比安慰剂组体重增加更多（0.89千克对 -0.63千克，平均差值1.52千克，p < 0.0001）。两组安全性相当，罗格列酮耐受性良好。
0.5毫克罗格列酮在疗效和安全性方面表现出良好的平衡。结果支持罗格列酮在治疗2型糖尿病方面的潜在作用。
Clinicaltrials.gov NCT01001611。
