Efficacy and safety of lobeglitazone monotherapy in patients with type 2 diabetes mellitus over 24-weeks: a multicenter, randomized, double-blind, parallel-group, placebo controlled trial.
Efficacy and safety of lobeglitazone monotherapy in patients with type 2 diabetes mellitus over 24-weeks: a multicenter, randomized, double-blind, parallel-group, placebo controlled trial.
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DOI：
10.1371/journal.pone.0092843
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发表时间：
2014
期刊：
影响因子：
3.7
通讯作者：
Choi DS
中科院分区：
文献类型：
--
作者：
Kim SG;Kim DM;Woo JT;Jang HC;Chung CH;Ko KS;Park JH;Park YS;Kim SJ;Choi DS
本研究的目的是评估洛格列酮（一种新型过氧化物酶体增殖物激活受体-γ激动剂）与安慰剂作为 2 型糖尿病患者单一疗法的降糖和调脂作用以及安全性。在这项为期 24 周、多中心、随机、双盲、平行组、安慰剂对照研究中，173 名患者被随机分配（2:1 比例）服用洛格列酮 0.5 mg (n = 115) 或匹配安慰剂 (n = 58)，每天口服一次。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、血脂参数和安全性概况（ClinicalTrials.gov 编号 NCT01001611）。第 24 周时，与安慰剂相比，洛格列酮组的 HbA1c 显着降低（-0.44% vs 0.16%，平均差 -0.6%，p<0.0001）。与安慰剂组相比，洛格列酮组明显更多地实现了 HbA1c <7% 的目标（44% vs 12%，p<0.0001）。洛格列酮组的胰岛素抵抗指标也得到改善。此外，与安慰剂相比，洛格列酮治疗显着改善甘油三酯、高密度脂蛋白胆固醇、小密度低密度脂蛋白胆固醇、游离脂肪酸和载脂蛋白-B/CIII（分别p<0.01）。洛格列酮组比安慰剂组体重增加更多（0.89 kg vs – 0.63 kg，平均差 1.52 kg，p<0.0001）。两组之间的安全性相当，并且洛格列酮的耐受性良好。洛格列酮 0.5 mg 在疗效和安全性方面显示出良好的平衡。结果支持洛格列酮在治疗 2 型糖尿病中的潜在作用。临床试验.gov NCT01001611
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
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