Improvement of Insulin Sensitivity by a Novel Drug, BGP-15, in Insulin-resistant Patients: A Proof of Concept Randomized Double-blind Clinical Trial
Improvement of Insulin Sensitivity by a Novel Drug, BGP-15, in Insulin-resistant Patients: A Proof of Concept Randomized Double-blind Clinical Trial
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DOI：
10.1055/s-0028-1128142
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发表时间：
2009-05-01
影响因子：
2.2
通讯作者：
Koranyi, L.
中科院分区：
文献类型：
--
作者：
Literati-Nagy, B.;Kulcsar, E.;Koranyi, L.
在一项为期 28 天的剂量范围研究中，将新药 BGP-15 与安慰剂在胰岛素抵抗患者中的疗效和安全性进行了比较。 47 名糖耐量受损的非糖尿病患者被随机分配接受 4 周的 200 或 400 mg BGP-15 或安慰剂治疗。采用高胰岛素正常血糖钳夹技术和稳态模型评估方法测定胰岛素抵抗，并通过静脉内葡萄糖耐量试验测定P细胞功能。与基线和安慰剂相比，每个 BGP-15 剂量均显着增加全身胰岛素敏感性（M-1，p=0.032）、全身葡萄糖利用率（M-2，p=0.035）、肌肉组织葡萄糖利用率（M-3，p=0.040）和去脂体重葡萄糖利用率（M-4，p=0.038）。治疗期间未观察到药物不良反应。与安慰剂相比，200 或 400 mg 的 BGP-15 在治疗期间显着改善了胰岛素抵抗的非糖尿病患者的胰岛素敏感性，并且安全且耐受性良好。这是第一项证明分子具有胰岛素增敏作用的临床研究，该分子被认为是热休克蛋白的共同诱导物。
The efficacy and safety of the new drug, BGP-15, were compared with placebo in insulin-resistant patients in a 28-day dose-ranging study. Forty-seven nondiabetic patients with impaired glucose tolerance were randomly assigned to 4 weeks of treatment with 200 or 400 mg of BGP-15 or placebo. Insulin resistance was determined by hyperinsulinemic euglycemic clamp technique and homeostasis model assessment method, and P-cell function was measured by intravenous glucose tolerance test. Each BGP-15 dose significantly increased whole body insulin sensitivity (M-1, p=0.032), total body glucose utilization (M-2, p=0.035), muscle tissue glucose utilization (M-3, p=0.040), and fat-free body mass glucose utilization (M-4, p=0.038) compared to baseline and placebo. No adverse drug effects were observed during treatment. BGP-15 at 200 or 400 mg significantly improved insulin sensitivity in insulin-resistant, nondiabetic patients during treatment compared to placebo and was safe and well-tolerated. This was the first clinical study demonstrating the insulin-sensitizing effect of a molecule, which is considered as a co-inducer of heat shock proteins.