NCT00568984已完成4 期
Efficacy and Safety of Repaglinide and Metformin Combined in Type 2 Diabetes Mellitus
适应症
相关药物
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 324
- 试验地点
- 16
- 主要终点
- HbA1c
研究概览
简要总结
This trial is conducted in Asia. The aim of this trial is to investigate the efficacy of blood glucose control with combination therapy of repaglinide and metformin compared to conventional treatment with a sulphonylurea or metformin in monotherapy in 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
- None
入排标准
- 年龄范围
- 18 Years 至 99 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Type 2 diabetes for at least 3 months
- •No previous treatment for diabetes
- •HbA1c between 7.0-12.0%
- •Body Mass Index (BMI) between 19.0-40.0 kg/m2
排除标准
- •Type 1 diabetes
- •Known unstable/untreated proliferative retinopathy
- •Uncontrolled treated/untreated hypertension
- •Pregnancy, breast-feeding, the intention of becoming pregnant or judged to be using inadequate contraceptive measures
结局指标
主要结局
HbA1c
时间窗: after 16 weeks of treatment
次要结局
- Glucose profiles
- Quality of life assessment
- Treatment satisfaction
- Hypoglycaemic events
- Adverse events
研究者
研究点 (16)
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