NCT00102388已完成3 期
Efficacy and Safety of Vildagliptin Compared to Gliclazide in Drug Naive 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
- 1,092
- 试验地点
- 2
- 主要终点
- Change from baseline in HbA1c at 104 weeks
研究概览
简要总结
This study is not being conducted in the United States. The purpose of this study is to assess the safety and effectiveness of vildagliptin, an unapproved drug, compared to gliclazide in lowering overall blood glucose levels in people with type 2 diabetes who have not been previously treated with drug therapy to lower their blood sugar.
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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Not currently on drug therapy for type 2 diabetes
- •Body mass index (BMI) in the range 22-45
- •Blood glucose criteria must be met
排除标准
- •Pregnancy or lactation
- •Type 1 diabetes
- •Evidence of significant diabetic complications
- •Evidence of serious cardiovascular conditions
- •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)
Gliclazide
Active Comparator
干预措施: Gliclazide (Drug)
结局指标
主要结局
Change from baseline in HbA1c at 104 weeks
时间窗: 104 weeks
次要结局
- Patients with endpoint HbA1c <7% after 104 weeks(104 weeks)
- Change from baseline in fasting plasma glucose at 104 weeks(104 weeks)
- Patients with reduction in HbA1x >/= 0.5% after 104 weeks(104 weeks)
- Adverse event profile at 104 weeks(104 weeks)
- Patients with reduction in HbA1c >/= 0.7% after 104 weeks(104 weeks)
研究者
研究点 (2)
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