NCT00099918已完成3 期
Efficacy and Safety of Vildagliptin Compared to Rosiglitazone in Drug Naive Patients With Type 2 Diabetes
适应症
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 717
- 试验地点
- 3
- 主要终点
- Change from baseline in HbA1c at 24 weeks
研究概览
简要总结
The purpose of this study is to assess the safety and effectiveness of vildagliptin, an unapproved drug, compared to rosiglitazone in lowering overall blood glucose levels in people with type 2 diabetes who have not previously been 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
- Double
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Blood glucose criteria must be met
- •Not currently on drug therapy for type 2 diabetes
- •Body mass index (BMI) in the range 22-45
排除标准
- •Pregnancy or lactation
- •Type 1 diabetes
- •Evidence of serious diabetic complications
- •Evidence of serious cardiovascular conditions
- •Laboratory value abnormalities as defined by the protocol
- •Other protocol-defined exclusion criteria may apply
结局指标
主要结局
Change from baseline in HbA1c at 24 weeks
次要结局
- Patients with reduction in HbA1c >/= 0.7% after 24 weeks
- Change from baseline in fasting plasma glucose at 24 weeks
- Adverse event profile after 24 weeks of treatment
- Patients with endpoint HbA1c <7% at 24 weeks
- Change from baseline in HbA1c at 24 weeks for patients with high baseline HbA1c vs. low baseline HbA1c
研究者
研究点 (3)
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