NCT00359112已完成3 期
A Randomised, Multi-Centre, Phase IV, Double-Blind, Parallel Group Study Comparing the Effects of 52 Weeks Administration of AVANDAMET and Metformin Plus Sulphonylurea on Change in HbA1c From Baseline in Overweight Type 2 Diabetics Poorly Controlled on Metformin.
适应症
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 544
- 试验地点
- 143
- 主要终点
- Change in HbA1c level from baseline following 52 weeks of treatment.
研究概览
简要总结
This study compares the effects of Avandamet (rosiglitazone maleate/metformin) treatment and metformin plus sulphonylurea treatment in overweight people 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
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Body mass index > or = to 25 kg/m
- •HbA1c > or =7% and < or =10% at screening.
- •FPG > or = 7.0mmol/L (126mg/dL) at visit
- •Receiving at least 0.85g of metformin at constant dose(s) for at least 8 weeks prior to visit 1a.
- •Female subjects must be postmenopausal or using effective contraceptive measures.
排除标准
- •Use of any other oral antidiabetic drug other than metformin within 12 weeks prior to screening.
- •Subjects with clinically significant ongoing oedema requiring pharmacological treatment or with a history of oedema requiring pharmacological treatment.
- •Subjects with a history of severe hypoglycaemia.
- •Renal disease or renal dysfunction.
- •Presence of clinically significant hepatic disease.
- •Presence of unstable or severe angina or known NYHA grade I-IV congestive heart failure.
- •Subjects who have had a previous myocardial infarction, percutaneous transluminal coronary angioplasty, coronary artery bypass graft or cerebrovascular accident within 3 months prior to screening.
结局指标
主要结局
Change in HbA1c level from baseline following 52 weeks of treatment.
次要结局
- Change in FPG (fasting plasma glucose)
- insulin sensitivity
- beta cell function
- change in PAI-1
- CRP
- number of hypoglycaemic events
- Change in 24 hr ABPM
- Diabetes treatment satisfaction.
研究者
研究点 (143)
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