NCT00099866已完成3 期
Efficacy and Safety of Vildagliptin Compared to Metformin 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
- 570
- 试验地点
- 1
- 主要终点
- Change from baseline in HbA1c at 52 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 metformin 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
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Not currently on durg therapy for type 2 diabetes
- •Body mass index (BMI) in the range 22-45
- •Blood glucose criteria must be met
排除标准
- •Type 1 diabetes
- •Pregnancy or lactation
- •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
研究组 & 干预措施
Vildagliptin
Experimental
干预措施: vildagliptin (Drug)
Metformin
Active Comparator
干预措施: Metformin Comparator (Drug)
结局指标
主要结局
Change from baseline in HbA1c at 52 weeks
次要结局
- Change from baseline in body weight at 52 weeks
- Change from baseline in fasting plasma glucose at 52 weeks
- Change from baseline in fasting lipids at 52 weeks
- Adverse event profile after 52 weeks of treatment
- Change from baseline in HOMA B at 52 weeks
研究者
研究点 (1)
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