NCT00908921已完成4 期
Efficacy and Safety of Glimepiride as Oral Anti-Diabetic (OAD) Initiation Mono- Therapy in Chinese Type 2 Diabetes Mellitus (T2DM)
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
- Sanofi
- 入组人数
- 391
- 试验地点
- 1
- 主要终点
- Change in glycosylated hemoglobin (HbA1c) rate
研究概览
简要总结
To investigate the glycosylated hemoglobin (HbA1c) control of Glimepiride (AMARYL) as OAD initiation mono-therapy in type 2 diabetic patients in China.
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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Newly diagnosed T2DM and inadequately controlled with diet and exercise or T2DM diagnosed <6 months and who had not taken oral antidiabetic medication or insulin for >3months.
- •HbA1C more than 7.5 and less than 11.
排除标准
- •Fasting plasma glucose of >13.5mmol/L
- •Type 1 Diabetes Mellitus (T1DM)
- •Patient with acute illness hospitalized in last 2 months
- •Patient with active liver disease, impaired renal or hepatic functions
- •Known hypersensitivity to glimepiride, other sulfonylureas, other sulfonamides or any other excipients of AMARYL
- •Pregnant and lactating women
- •The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.
研究组 & 干预措施
1
Experimental
The treatment period is 16 weeks with 5 visits: at weeks 2, 4, 8, 12, 16. At every visit if Fasting Blood Glucose (FBG) >7.0mmol/L the Glimepiride dosage is increased from 1mg to 2mg or 2mg to 4mg.
At every visit if FBG<3.9mmol/L the Glimepiride dosage is decreased from 4mg to 2mg or 2mg to 1mg.
Patients who have been on 4mg for 4 weeks and FBG>11.0mmol/L at visit, another treatment can be added at the physician's discretion.
干预措施: GLIMEPIRIDE (Drug)
结局指标
主要结局
Change in glycosylated hemoglobin (HbA1c) rate
时间窗: week 16
次要结局
- Fasting Plasma Glucose (FPG) rate(week 16)
- Post Prandial Glucose (PPG) rate(week 16)
- Percentage of patients achieving HbA1c <7.0(week 16)
研究者
研究点 (1)
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