NCT00101803已完成3 期
Efficacy and Safety of Vildagliptin in Combination With Pioglitazone 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
- 527
- 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
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 the combination of vildagliptin, an unapproved drug, and pioglitazone 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 previously treated with oral antidiabetic agents 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 serious diabetic complications
- •Evidence of serious cardiovascular complications
- •Laboratory value abnormalities as defined by the protocol
- •Known sensitivity to pioglitazone
- •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
- Change from baseline in fasting plasma glucose at 24 weeks
- Adverse event profile after 24 weeks of treatment
- Patients with endpoint HbA1c <7% after 24 weeks
- Patients with endpoint HbA1C <6.5% after 24 weeks
- Patients with reduction in HbA1c >/= to 0.7% after 24 weeks
研究者
研究点 (2)
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