NCT00351884已完成3 期
A Multicenter, Double-blind, Randomized, Parallel-Group Study to Compare the Effect of 24 Weeks Treatment With Vildagliptin 100 MG QD to Placebo as Add-on Therapy in Patients With Type 2 Diabetes Inadequately Controlled With Metformin Monotherapy
适应症
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 370
- 试验地点
- 2
- 主要终点
- Change from baseline in HbA1c at 24 weeks
研究概览
简要总结
Vildagliptin is an oral anti-diabetic agent. This is a 24-week study to assess the efficacy on HbA1c of 100 mg vildagliptin once daily as compared to placebo as add-on to metformin in patients with type 2 diabetes inadequately controlled with metformin.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Triple (Participant, Care Provider, Investigator)
入排标准
- 年龄范围
- 18 Years 至 78 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients on metformin for at least three months and on a stable dose of at least 1500 mg daily for a minimum of 4 weeks prior to visit 1
- •Body mass index in the range 22-40
- •Blood glucose criteria must be met
排除标准
- •Pregnancy or lactation
- •History of type 1 diabetes
- •Evidence of significant diabetic complications
- •Other protocol-defined inclusion/exclusion criteria may apply
研究组 & 干预措施
vildagliptin am
Experimental
干预措施: Vildagliptin AM (Drug)
vildagliptin pm
Experimental
干预措施: vildagliptin pm (Drug)
placebo
Placebo Comparator
干预措施: placebo (Drug)
结局指标
主要结局
Change from baseline in HbA1c at 24 weeks
时间窗: 24 weeks
次要结局
- Safety of vildagliptin in combination with metformin during 24 weeks of treatment(24 weeks)
- Change from baseline in fasting plasma glucose at 24 weeks(24 weeks)
- Patients with endpoint HbA1c < 7% after 24 weeks(24 weeks)
- Patients with reduction in HbA1c greater than or equal to 0.7% after 24 weeks(24 weeks)
- Change from baseline in body weight at 24 weeks(24 weeks)
研究者
研究点 (2)
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