NCT00120536已完成3 期
Efficacy and Safety of Three Doses of Vildagliptin 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
- 发起方
- Novartis
- 入组人数
- 288
- 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
The purpose of this study is to assess the long term safety and effectiveness of three doses of vildagliptin, an unapproved drug, compared to placebo 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
- •Not currently on drug therapy for type 2 diabetes
- •Blood glucose criteria must be met
- •Body mass index (BMI) in the range 22-45
排除标准
- •History of type 1 diabetes
- •Evidence of significant diabetic complications
- •Serious cardiovascular events within the past 6 months
- •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
- Adverse event profile after 24 weeks of treatment
- Change from baseline in HbA1c at 24 weeks for patients with high baseline HbA1c vs. low baseline HbA1c
- Change from baseline in fasting plasma glucose at 24 weeks
- Patients with reduction in HbA1c >/= 0.7% after 24 weeks
- Patients with endpoint HbA1c < 7% after 24 weeks
研究者
研究点 (2)
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