NCT00279045已完成3 期
A Randomized, Double-Blind Study to Compare the Durability of Glucose Lowering and Preservation of Pancreatic Beta-Cell Function of Rosiglitazone Monotherapy Compared to Metformin or Glyburide/Glibenclamide in Patients With Drug-Naive, Recently Diagnosed Type 2 Diabetes Mellitus
适应症
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 4,426
- 试验地点
- 490
- 主要终点
- Time from randomization to the primary action point (monotherapy failure).
研究概览
简要总结
The study will compare and evaluate the effects of long-term treatment of monotherapy with rosiglitazone, metformin and glyburide/glibenclamide on the improvement and maintenance of glycemic control in patients with recently diagnosed type 2 diabetes mellitus.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
入排标准
- 年龄范围
- 30 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Newly diagnosed patients (< 3years) with type 2 diabetes.
- •Fasting plasma glucose (FPG) range of 126-240 mg/dL at Screening.
- •No previous treatment with oral or parenteral glucose-lowering therapy.
排除标准
- •History of lactic acidosis.
- •Anemia (<11g for males, <10 g for females).
- •Unstable or severe NY Heart Association-class 3 or
- •Any NY Heart Association congestive heart failure.
- •Patients with chronic diseases requiring periodic or intermittent treatment with oral or intravenous corticosteroids.
结局指标
主要结局
Time from randomization to the primary action point (monotherapy failure).
次要结局
- Comparison of effects of long-term treatment with Rosiglitazone, Metformin, Glyburide: - maintenance/restoration of beta-cell function: HOMA IS, progression of microalbuminuria, fibrinolytic markers (PAI-1,fibrinogen, CRP).
研究者
研究点 (490)
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