NCT01144728已完成4 期
AMIT Study - Amaryl M Initiation and Titration Study
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
- 172
- 试验地点
- 1
- 主要终点
- Glycolysated Haemoglobin (HbA1c)
研究概览
简要总结
Primary Objective:
- To describe the conditions of initiation and titration of Amaryl M, according to previous treatment:
- initial dose
- titration scheme
- efficacy after 4 months assessed by HbA1C
- tolerability (number and severity of hypoglycaemia)
Secondary Objective:
- Fasting Plasma Glucose
- Weight evolution
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
- 35 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- 未提供
排除标准
- 未提供
研究组 & 干预措施
Single arm Glimepiride+metformin
Experimental
Start and titration based on FBG and tolerance. Titration should be achieved within maximum 4 weeks.
干预措施: GLIMEPIRIDE + METFORMIN (Drug)
结局指标
主要结局
Glycolysated Haemoglobin (HbA1c)
时间窗: From baseline to Month 4
Patients With Glycosylated Haemoglobin (HbA1c) Value < 7%
时间窗: Month 4
Evolution of Fasting Plasma Glucose (FPG)
时间窗: From baseline to Months 4
次要结局
- Post Prandial Plasma Glucose (PPPG)(Month 4)
- Number of patients for each start dose(At baseline)
- Number of patients with different final doses(Month 4)
- Rate of Symptomatic Hypoglycemia(During treatment period (4 months))
- Change in Weight(Month 4)
研究者
研究点 (1)
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