NCT00237250已完成3 期
Efficacy and Safety of Vildagliptin in Subjects With Impaired Glucose Tolerance
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
- 171
- 试验地点
- 2
- 主要终点
- Change in area under the 0-2 hour prandial glucose curve at 12 weeks
研究概览
简要总结
The purpose of this study is to assess the safety and effectiveness of vildagliptin, an unapproved drug, compared to placebo in lowering post-meal blood glucose levels in people with pre-diabetes who have high blood sugar levels after meals.
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
- •Blood glucose criteria must be met
- •Body mass index (BMI) in the range 23-45
排除标准
- •Diagnosis of diabetes
- •Serious cardiovascular events within the past 6 months
- •Use of insulin or any oral antidiabetic agent
- •Other protocol-defined exclusion criteria may apply
结局指标
主要结局
Change in area under the 0-2 hour prandial glucose curve at 12 weeks
次要结局
- Adverse event profile after 12 weeks of treatment
- Change in ratio for postprandial insulin AUC and postprandial glucose AUC (0-2 hours) after 12 weeks of treatment
- Change in HOMA B at 12 weeks
- Change in fasting insulin at 12 weeks
- Change in fasting proinsulin/insulin ratio at 12 weeks
研究者
研究点 (2)
Loading locations...
相似试验
已完成
3 期
Efficacy and Safety of Vildagliptin Compared to Metformin in Drug Naive Patients With Type 2 DiabetesDiabetes Mellitus, Type 2NCT00099866Novartis Pharmaceuticals570
已完成
3 期
Efficacy and Safety of Vildagliptin Compared to Rosiglitazone in Drug Naive Patients With Type 2 DiabetesDiabetes Mellitus, Type 2NCT00099918Novartis Pharmaceuticals717
已完成
1 期
Safety, Tolerability, Effect of Vildagliptin and How the Body Changes the Blood Level of Vildagliptin in Healthy Chinese VolunteersHealthyNCT00419887Novartis60
已完成
不适用
Efficacy and Safety of Vildagliptin in Type 2 DiabetesCTRI/2022/01/039112Cipla Limited1,691
未知
3 期
To assess the efficacy and safety of vildagliptin as add-on therapy to sulfonylurea in patients with type 2 diabetes inadequately controlled with sulfonylurea monotherapyType 2 DiabetesJPRN-jRCT2080220244ovartis Pharma K.K.200