NCT00101712已完成3 期
Efficacy and Safety of Vildagliptin Compared to Placebo in Patients With Type 2 Diabetes and Mild Hyperglycemia
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
- 274
- 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
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 assess the 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 (Participant, Investigator)
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
- •Blood glucose criteria must be met
- •Not currently on drug therapy for type 2 diabetes
- •Body mass index (BMI) in the range 22-45
- •Diagnosis of type 2 diabetes for at least 8 weeks
排除标准
- •Pregnancy or lactation
- •Type 1 diabetes
- •Evidence of serious diabetic complications
- •Evidence of serious cardiovascular complications
- •Significant laboratory 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)
Placebo
Placebo Comparator
干预措施: Vildagliptin Placebo (Drug)
结局指标
主要结局
Change from baseline in HbA1c at 52 weeks
次要结局
- Adverse event profile after 52 weeks of treatment
- Patients with HbA1c <6.5% at 12 weeks
- Patients with HbA1c <6.5% at 52 weeks
- Change from baseline in fasting plasma glucose at 52 weeks
- Coefficient of failure for HbA1c between 24 weeks and 52 weeks
研究者
研究点 (1)
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