NCT00468039已完成3 期
A Multicenter, Open-label Sub-study to LMF237A2302 to Assess the Effect of 24 Weeks Treatment With Initial Combination of Vildagliptin 100mg qd Plus Metformin 1000mg Bid in Drug Naive Patients With Type 2 Diabetes With Very Poor Glycemic Control
适应症
干预措施
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
- 94
- 试验地点
- 1
- 主要终点
- glycosylated hemoglobin (HbA1c)at Baseline and week 24
研究概览
简要总结
This study will evaluate the effects of treatment with vildagliptin and metformin as initial combination in newly diagnosed patients with type 2 diabetes who have very high levels of HbA1c and/or fasting plasma glucose.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 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 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 type 2 diabetes for at least 4 weeks prior to study entry
- •Body mass index 22-40 kg/meter squared
- •HbA1c > 11% and/or FPG >270 mg/dL
排除标准
- •Pregnant or lactating female
- •History of type 1 diabetes
- •Evidence of significant diabetic complications
- •Treatment with insulin or any other oral antidiabetic agent
- •Other protocol-defined inclusion/exclusion criteria may apply.
研究组 & 干预措施
vildagliptin + metformin
Experimental
干预措施: vildagliptin + metformin (Drug)
结局指标
主要结局
glycosylated hemoglobin (HbA1c)at Baseline and week 24
时间窗: 24 weeks
次要结局
- Weight at baseline and week 24(24 weeks)
- Responder rates assessed by HbA1c absolute reduction from baseline to endpoint greater than or equal to 0.7% after 24 weeks(24 weeks)
- Fasting plasma glucose test (FPG) at Baseline and week 24(24 weeks)
- HbA1c at Baseline and week 12(12 weeks)
- Safety assessed by monitoring and recording all adverse events, serious adverse events.(24 weeks)
研究者
研究点 (1)
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