NCT00300287已完成3 期
A 56-Week Extension to a Clinical Study to Assess the Efficacy and Safety of Vildagliptin Compared to Placebo in Drug Naive Patients With Type 2 Diabetes and Mild Hyperglycemia
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
- 150
- 试验地点
- 1
- 主要终点
- Change from baseline in HbA1c at 108 weeks
研究概览
简要总结
This study is not being conducted in the United States. Key long-term clinical studies have shown that people with type 2 diabetes should try to achieve overall blood glucose levels as close to normal as possible. The purpose of this study is to gather data on the long-term safety and effectiveness of vildagliptin, an unapproved drug, compared to placebo 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 and whose blood glucose levels are close to normal.
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
- 19 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Completion of study CLAF237A2307 within 4 weeks of entering into the extension
- •Written informed consent
- •Ability to comply with all study requirements
- •Blood glucose criteria must be met
排除标准
- •Premature discontinuation from study CLAF237A2307
结局指标
主要结局
Change from baseline in HbA1c at 108 weeks
次要结局
- Adverse event profile after 108 weeks of treatment
- Change in HbA1c from week 52 to week 108
- Change from baseline in fasting plasma glucose at week 108
- Change in fasting plasma glucose from week 52 to week 108
- Change from baseline in body weight at week 108
研究者
研究点 (1)
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