NCT00382096已完成3 期
A Randomized, Double-blind, Active-controlled, Multicenter Study to Compare the Effect of 24 Weeks Treatment With a Fixed Combination Therapy of Vildagliptin and Metformin to the Individual Monotherapy Components in Drug Naive 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
- 1,179
- 试验地点
- 1
- 主要终点
- Change from baseline in HbA1c
研究概览
简要总结
The purpose of this study is to evaluate the efficacy and safety of a fixed combination of vildagliptin and metformin in lowering blood glucose in patients with type 2 diabetes
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 78 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Male or female (non-fertile or of childbearing potential using a medically approved birth control method) patients with type 2 diabetes
- •Diagnosis of T2DM for at least 4 weeks prior to study entry
- •Age 18 - 78 years inclusive
- •Body mass index (BMI) of 22 - 40 kg/m2
- •HbA1c: 7.5 - 11% inclusive
- •FPG <270 mg/dL (15 mmol/L)
- •Exclusion Criteria
- •Pregnant or lactating female
- •A history of type 1 diabetes
- •Evidence of significant diabetic complications
- •Other protocol-defined inclusion/exclusion criteria may apply
排除标准
- 未提供
研究组 & 干预措施
Vildagliptin + Metformin Dose 1
Experimental
干预措施: Vildagliptin + Metformin (Drug)
Vildagliptin + Metformin Dose 2
Experimental
干预措施: Vildagliptin + Metformin (Drug)
Vildagliptin
Active Comparator
干预措施: Vildagliptin (Drug)
Metformin
Active Comparator
干预措施: Metformin (Drug)
结局指标
主要结局
Change from baseline in HbA1c
时间窗: At week 24
次要结局
- Change from baseline in fasting plasma glucose(At week 24)
- Percent of patients with reduction in HbA1c >/=0.7%(At week 24)
- Percent of patients with endpoint HbA1c <7%(At week 24)
- Adverse event profile after treatment(At week 24)
- Change from baseline in body weight(At week 24)
研究者
研究点 (1)
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