Multicenter, randomized, double-masked, parallel-group assessment of simultaneous glipizide/metformin as second-line pharmacologic treatment for patients with type 2 diabetes mellitus that is inadequately controlled by a sulfonylurea
Multicenter, randomized, double-masked, parallel-group assessment of simultaneous glipizide/metformin as second-line pharmacologic treatment for patients with type 2 diabetes mellitus that is inadequately controlled by a sulfonylurea
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DOI：
10.1016/s0149-2918(03)80112-1
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发表时间：
2003-03-01
影响因子：
3.2
通讯作者：
Rubin, CJ
中科院分区：
文献类型：
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作者：
Goldstein, BJ;Pans, M;Rubin, CJ
背景：许多 2 型糖尿病 (DM) 患者使用磺酰脲类或二甲双胍单一疗法无法长期控制血糖，需要额外治疗。格列吡嗪与二甲双胍联合治疗对血糖控制的协同作用可以通过治疗 2 型糖尿病、胰岛素分泌受损和胰岛素抵抗等主要影响来实现。 目的：本研究评估了格列吡嗪/二甲双胍联合片剂对 2 型糖尿病患者的治疗效果，这些患者无法通过磺脲类药物每日最大标记剂量的至少一半进行控制。 方法：在这项多中心、双盲、平行组、主动对照研究中，患者被随机分配接受治疗格列吡嗪 30 mg、二甲双胍 500 mg 或格列吡嗪/二甲双胍 5/500 mg 片剂，持续 18 周（调整二甲双胍和格列吡嗪/二甲双胍剂量以实现血糖控制）。每日最大总剂量为格列吡嗪 30 mg、二甲双胍 2000 mg 和格列吡嗪/二甲双胍 20/2000 mg。 结果：本研究共纳入 247 名患者。平均 (SD) 年龄为 56.2 (10.1) 岁； 61.5%的患者为男性； 70.0% 为白人，15.8% 为西班牙裔/拉丁裔，13.0% 为黑人，1.2% 为亚洲/太平洋岛民。患者平均肥胖（平均 [SD] 体重指数为 31.3 [4.7] kg/m(2)），患有中度至重度高血糖（平均 [SD] 糖化血红蛋白 [HbA(1c)]， 8.7% [1.1])，平均 (SD) DM 持续时间为 6.5 (4.9) 年。格列吡嗪/二甲双胍片剂控制 HbA(1c) 水平比格列吡嗪或二甲双胍单一疗法更有效（平均治疗差异，有利于格列吡嗪/二甲双胍，分别为 -1.06% 和 -0.98%，P < 0.001）。研究结束时，HbA(1c) 水平
Background: Many patients with type 2 diabetes mellitus (DM) with inadequate long-term blood glucose control with sulfonylurea or metformin monotherapy require additional treatment. The synergistic effects of combining glipizide with metformin on glucose control may be realized by treating the primary effects of type 2 DM, impaired insulin secretion, and insulin resistance.Objective: This study assessed therapy with glipizide/metformin combination tablets in patients with type 2 DM that is uncontrolled by at least half the maximum labeled daily dose of a sulfonylurea.Methods: In this multicenter, double-masked, parallel-group, active-controlled study, patients were randomized to receive glipizide 30-mg, metformin 500-mg, or glipizide/metformin 5/500 mg tablets for 18 weeks (metformin and glipizide/metformin doses were titrated to achieve blood glucose control). Maximum total daily doses were glipizide 30 mg, metformin 2000 mg, and glipizide/metformin 20/2000 mg.Results: A total of 247 patients were included in the study The mean (SD) age was 56.2 (10.1) years; 61.5% of patients were male; 70.0% were white, 15.8% were Hispanic/Latino, 13.0% were black, and 1.2% were Asian/Pacific Islanders.Patients were, on average, obese (mean [SD] body mass index, 31.3 [4.7] kg/m(2)), had moderate to severe hyperglycemia (mean [SD] glycated hemoglobin [HbA(1c)], 8.7% [1.1]), and had a mean (SD) DM duration of 6.5 (4.9) years. Glipizide/metformin tablets controlled the HbA(1c) level more effectively than did either glipizide or metformin monotherapies (mean treatment differences, in favor of glipizide/metformin, of -1.06% and -0.98%, respectively, P < 0.001). At study end, an HbA(1c) level