NCT01196546已完成4 期
Multi-center, Open-label, 24-week Study to Demonstrate the Efficacy and Safety of Combination Therapy of Vildagliptin/Metformin 50/500 or 50/1000 mg Twice Daily in Patients With T2DM Inadequately Controlled With Metformin
适应症
干预措施
相关药物
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- Novartis
- 入组人数
- 161
- 试验地点
- 8
- 主要终点
- HbA1c reduction
研究概览
简要总结
This study will assess the efficacy and safety of combination therapy of vildagliptin/metformin in patients with T2DM inadequately controlled with metformin 1,000 mg/day.
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
- 是
入选标准
- •Type 2 Diabetes mellitus patients who are treated with metformin monotherapy 1,000 mg daily for at least 3 months
- •The patient is required to have HbA1c 6.5-11.0%
- •BMI in the range of 22-48 kg/m2
排除标准
- •Severe or uncontrolled Type 2 diabetes mellitus (HbA1c> 11.0%)
- •Acute metabolic diabetes complications such as ketoacidosis or hyperosmolar state (coma) within the past 6 months
- •Congestive heart failure requiring pharmacologic treatment
- •Any of following within past 6 months: (1) myocardial infarction; (2) unstable angina (3) coronary artery bypass surgery or percutaneous coronary intervention
- •Liver disease such as cirrhosis or chronic active hepatitis
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
HbA1c reduction
时间窗: 24 weeks after treatment
次要结局
- Proportion of patients who achieve target of HbA1c<6.5% at the end of study(24 weeks after treatment)
- To evaluate the effect of combination therapy of vildagliptin (50 mg) plus metformin (500 or 1000 mg) twice daily on FPG and BMI, safety and tolerability profiles(24 weeks after treatment)
研究者
研究点 (8)
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