An Open-labeled, Randomized, Multicenter, Prospective, Parallel Group, Interventional Study to Demonstrate the Effectiveness of 24 Weeks Treatment With Vildagliptin 50mg Bid as Add on to Metformin 500 mg Bid Compared to Metformin up to 1000 mg Bid in Chinese Patients With Type 2 Diabetes Inadequately Controlled on Metformin 500 mg Bid Monotherapy .
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 3,091
- 试验地点
- 1
- 主要终点
- Change from baseline in hemoglobin A1c(HbA1C) after 24 weeks of treatment with vildagliptin
研究概览
简要总结
This is an open-labeled, randomized, multicenter, prospective, parallel group, interventional study to demonstrate the effectiveness of 24 weeks treatment with Vildagliptin 50mg bid as add on to metformin 500 mg bid compared to metformin up to 1000 mg bid in Chinese patients with type 2 diabetes inadequately controlled on sub maximal dosage metformin monotherapy.
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
- None
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
- •Chinese T2D patients who are inadequate controlled (6.5 %< HbA1C ≤9%) by metformin (≥750mg/d but ≤1000mg/d, ≥12 weeks),
排除标准
- •Type 1 diabetes and secondary diabetes
- •Acute metabolic diabetic complications within the past 3 months.
- •Acute infections which may influence glucose level.
- •Evidence of significant chronic diabetic complications,
- •Clinically significant renal impairment and hepatic impairment patients, including history of cirrhosis or chronic hepatitis,
- •FPG > 270 mg/dl (15 mmol/l)
- •Any of the following disease within the past 6 months: myocardial infarction (MI); coronary artery bypass surgery or percutaneous coronary intervention; unstable angina or stroke; Congestive heart failure (CHF)
- •Other protocol-defined inclusion/exclusion criteria may apply
研究组 & 干预措施
metformin up titration
metformin 500 mg bid will be up titrated (total daily dose up to 2000 mg)
干预措施: Metformin (Drug)
vildagliptin add on to metformin
Vildagliptin 50 mg twice daily + Metformin 500mg twice daily
干预措施: Metformin (Drug)
vildagliptin add on to metformin
Vildagliptin 50 mg twice daily + Metformin 500mg twice daily
干预措施: vildagliptin (Drug)
结局指标
主要结局
Change from baseline in hemoglobin A1c(HbA1C) after 24 weeks of treatment with vildagliptin
时间窗: baseline, 24 weeks
The change from baseline in hemoglobin A1c(HbA1c) after 24 weeks treatment in vildagliptin 50 mg bid used in combination with metformin 500 mg bid is not inferior to that with metformin up to 1000 mg bid as monotherapy after 24 weeks
次要结局
- Change from baseline in hemoglobin A1c(HbA1C) after 24 weeks of treatment in pre-defined patient subgroups(baseline and 24 weeks)
- Percentage of patients achieving target hemoglobin A1c( HbA1C) of ≤6.5%(baseline and 24 weeks)
- Percentage of patients achieving target hemoglobin A1c(HbA1C) of ≤6.5% without adverse gastrointestinal (GI) events(baseline and 24 weeks)
- Mean change from baseline in fasting plasma glucose (FPG)(baseline, 24 weeks)
- Mean change from baseline in 2-hour post prandial glucose( PPG) in a sub sample(baseline, 24 weeks)
- Number of patients with adverse events, serious adverse events and death(up to 24 weeks)