NCT01398592已完成4 期
Cross-over Study to Assess the Difference in Fasting Plasma Glucose (FPG) Between Vildagliptin (Galvus®/Eucreas®) and Sitagliptin (Januvia®/Janumet®) After Two Weeks
适应症
干预措施
相关药物
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 187
- 试验地点
- 1
- 主要终点
- demonstrate that the FPG after 14 days of treatment with Vildagliptin is superior to the FPG after 14 days of treatment with Sitagliptin
研究概览
简要总结
This study is designed to assess the potential difference in Fasting Plasma Glucose (FPG) lowering efficacy between the two DPP-4 inhibitors vildagliptin and sitagliptin, both after a two weeks treatment on top of metformin.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 85 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients with type 2 diabetes 18 to 85 years Metformin monotherapy > 4 weeks HbA1c 6.5 - 9.5%
排除标准
- •FPG > 270 mg/dl Use of other antidiabetic drugs than metformin major cardiovascular event in the last 6 months (MI, stroke...)
研究组 & 干预措施
Vildagliptin
Experimental
Experimental
干预措施: Vildagliptin (Drug)
Sitagliptin
Active Comparator
Active comparator (drug)
干预措施: Sitagliptin (Drug)
结局指标
主要结局
demonstrate that the FPG after 14 days of treatment with Vildagliptin is superior to the FPG after 14 days of treatment with Sitagliptin
时间窗: 14 days
Fasting Plasma Glucose measured on day 14.
次要结局
- To assess the difference in FPG between vildagliptin and sitagliptin in patients with type 2 diabetes mellitus on concomitant treatment with metformin(14 days)
研究者
研究点 (1)
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