NCT00102466已完成3 期
Vildagliptin Compared to Gliclazide in Combination With Metformin in Patients With Type 2 Diabetes
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
- 1,007
- 试验地点
- 2
- 主要终点
- Change from baseline in HbA1c at 52 weeks
研究概览
简要总结
This study is not being conducted in the United States. Many people with type 2 diabetes cannot maintain target blood glucose levels when taking a single oral drug. The purpose of this study is to assess the safety and effectiveness of vildagliptin, an unapproved drug, compared to that of gliclazide in lowering overall blood glucose levels when added to metformin in people with type 2 diabetes not at target blood glucose levels on metformin alone.
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
- Double (Participant, 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
- •On a stable dose of metformin as defined by the protocol
- •Blood glucose criteria must be met
- •Body mass index (BMI) in the range 22-45
排除标准
- •Pregnancy or lactation
- •Type 1 diabetes
- •Evidence of significant diabetic complications
- •Evidence of serious cardiovascular complications
- •Laboratory value abnormalities as defined by the protocol
- •Other protocol-defined exclusion criteria may apply
研究组 & 干预措施
Vildagliptin
Experimental
干预措施: vildagliptin (Drug)
Vildagliptin
Experimental
干预措施: Metformin (Drug)
Gliclazide
Active Comparator
干预措施: Gliclazide (Drug)
Gliclazide
Active Comparator
干预措施: Metformin (Drug)
结局指标
主要结局
Change from baseline in HbA1c at 52 weeks
时间窗: 52 weeks
次要结局
- Adverse event profile after 52 weeks of treatment(52 weeks)
- Change from baseline in fasting plasma glucose at 52 weeks(52 weeks)
- Patients with endpoint HbA1c <7% at 52 weeks(52 weeks)
- Patients with reduction in HbA1c >/= 0.7% after 52 weeks(52 weeks)
- Patients with reduction in HbA1c >/= 0.5% after 52 weeks(52 weeks)
研究者
研究点 (2)
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