Effects of vildagliptin on glucose control over 24 weeks in patients with type 2 diabetes inadequately controlled with metformin
Effects of vildagliptin on glucose control over 24 weeks in patients with type 2 diabetes inadequately controlled with metformin
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DOI：
10.2337/dc06-1732
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发表时间：
2007-04-01
期刊：
影响因子：
16.2
通讯作者：
Garber, Alan J.
中科院分区：
文献类型：
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作者：
Bosi, Emanuele;Camisasca, Riccardo Paolo;Garber, Alan J.
目的 - 我们试图评估维格列汀（一种新型二肽基肽酶 4 抑制剂）与二甲双胍联合治疗 2 型糖尿病患者 24 周的疗效和安全性。 研究设计和方法 - 这是一项双盲、随机、多中心、平行组研究，每天服用 50 毫克维格列汀（n - 177），每次 100 毫克，为期 24 周。维格列汀 对于继续稳定二甲双胍剂量方案（>= 1,500 mg/天）但血糖控制不充分（AlC 7.5-11%）的患者，每日一次（n = 185）或安慰剂（n = 182）。 结果 - 从基线到终点 AlC 的调整平均变化（AM Delta）+/- SE 的治疗间差异（维格列汀 - 安慰剂）为 每天接受 50 或 100 mg 维格列汀的住院患者分别为 -0.7-0.1% (P < 0.001) 和 -1.1 +/- 0.1% (P < 0.001)。每天接受 50 或 100 mg 维格列汀治疗的患者，治疗间 AM Delta 空腹血糖 (FPG) 差异分别为 - 0.8 +/- 0.3 mmol/l (P = 0.003) 和 -1.7 +/- 0.3 mmol/l (P < 0.001)。每日服用 50 mg 维格列汀、每日 100 mg 维格列汀或安慰剂的患者中分别有 63.3%、65.0% 和 63.5% 报告了不良事件 (AE)。每天接受 50 mg 维格列汀、每天 100 mg 维格列汀或安慰剂的患者分别有 9.6%（P = 0.022 与安慰剂）、14.8% 和 18.2% 的患者报告胃肠道 AE。每个治疗组中都有一名患者经历了一次轻度低血糖事件。 结论 - 维格列汀耐受性良好，作为二甲双胍控制不佳的 2 型糖尿病患者的附加治疗，可产生具有临床意义、密切相关的 AlC 和 FPG 下降。
OBJECTIVE - We sought to evaluate the efficacy and safety of vildagliptin, a new dipeptidyl peptidase-4 inhibitor, added to metformin during 24 weeks of treatment in patients with type 2 diabetes.RESEARCH DESIGN AND METHODS - This was a double-blind, randomize, multicenter, parallel group study of a 24-week treatment with 50 mg vildagliptin daily (n - 177), 100 mg vildagliptin daily (n = 185), or placebo (n = 182) in patients continuing a stable metformin dose regimen (>= 1,500 mg/day) but achieving inadequate glycemic control (AlC 7.5-11%).RESULTS - The between-treatment difference (vildagliptin - placebo) in adjusted mean change (AM Delta) +/- SE in AlC from baseline to end point was -0.7-0.1% (P < 0.001) and -1.1 +/- 0.1% (P < 0.001) inpatients receiving 50 or 100 mg vildagliptin daily, respectively. The between-treatment difference in the AM Delta fasting plasma glucose (FPG) was - 0.8 +/- 0.3 mmol/l (P = 0.003) and -1.7 +/- 0.3 mmol/l (P < 0.001) in patients receiving 50 or 100 mg vildagliptin daily, respectively. Adverse events (AEs) were reported by 63.3, 65.0, and 63.5% of patients receiving 50 mg vildagliptin daily, 100 mg vildagliptin daily, or placebo, respectively. Gastrointestinal AEs were reported by 9.6 (P = 0.022 vs. placebo), 14.8, and 18.2% of patients, receiving 50 mg vildagliptin daily, 100 mg vildagliptin daily, or placebo, respectively. One patient in each treatment group experienced one mild hypoglycemic event.CONCLUSIONS - Vildagliptin is well tolerated and produces clinically meaningful, close-related decreases in AlC and FPG as add-on therapy in patients with type 2 diabetes inadequately controlled by metformin.