NCT00106340已完成3 期
Vildagliptin Compared to Glimepiride in Combination With Metformin in 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
- 3,118
- 试验地点
- 2
- 主要终点
- Time to HbA1c >8%
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 long term safety and effectiveness of vildagliptin, an unapproved drug, compared to that of glimepiride in lowering overall blood glucose levels when added to metformin in people with type 2 diabetes not at target blood glucose levels on metformin alone.
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 73 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •On a stable dose of metformin as defined by the protocol
- •Body mass index (BMI) in the range 22-45
- •Blood glucose criteria must be met
排除标准
- •Pregnancy or lactation
- •Type 1 diabetes
- •Evidence of significant diabetic complications
- •Evidence of serious cardiovascular complications
- •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)
Vildagliptin
Experimental
干预措施: Metformin (Drug)
Vildagliptin
Experimental
干预措施: Glimepiride matching placebo (Drug)
Glimepiride
Active Comparator
干预措施: glimepiride (Drug)
Glimepiride
Active Comparator
干预措施: Metformin (Drug)
Glimepiride
Active Comparator
干预措施: Vildagliptin matching placebo (Drug)
结局指标
主要结局
Time to HbA1c >8%
时间窗: 2 year
次要结局
- Adverse event profile after 5 years of treatment(2 years (amended))
- Coefficient of failure for HbA1c from week 24 to 5 years(2 years (amended))
- Change from baseline in fasting plasma glucose at 5 years(2 years (amended))
- Change from baseline in body weight at 5 years(2 years (amended))
- Change from baseline in HbA1c at 5 years(2 years (amended))
研究者
研究点 (2)
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