NCT00138593已完成3 期
Extension to a Study of the Efficacy and Safety of Vildagliptin in Patients With Type 2 Diabetes With HbA1c 9-11%
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
- 180
- 试验地点
- 1
- 主要终点
- Safety in combination with pioglitizone after 52 weeks of treatment
研究概览
简要总结
This study is not being conducted in the United States. This is a 52-week extension to a study to assess the safety and effectiveness of two doses of vildagliptin, an unapproved drug, in lowering overall blood glucose levels in people with type 2 diabetes who had not previously been treated with drug therapy to lower their blood sugar and whose blood sugar levels were in a specified range. The purpose of the extension study is to gather data on the long term safety and effectiveness of vildagliptin in people with type 2 diabetes.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Only patients successfully completing study CLAF237A2329 are eligible
- •Written informed consent
- •HbA1c reduction from baseline to week 12 (visit 5) of the core study is greater than or equal to 0.3 absolute units
- •Ability to comply with all study requirements
排除标准
- •Premature discontinuation from study CLAF237A2329
- •Other protocol-defined exclusion criteria may apply
结局指标
主要结局
Safety in combination with pioglitizone after 52 weeks of treatment
Change from baseline in HbA1c at 52 weeks
次要结局
- Change from baseline in fasting plasma glucose at 52 weeks
- Change from baseline in fasting lipids at 52 weeks
- Change from baseline in body weight at 52 weeks
- Change from baseline in HOMA B at 52 weeks
- Change from baseline in HOMA IR at 52 weeks
研究者
研究点 (1)
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