NCT01204580已完成4 期
ADIponectin and ADMA Level in Type-2 Diabetes Patients After 12 Weeks of Treatment With GlimepiRide And Metformin Fixed Dose Combination (Amaryl-M)
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
- 40
- 试验地点
- 1
- 主要终点
- Adiponectin and Asymmetric Dimethylarginine (ADMA) plasma level changes
研究概览
简要总结
Primary Objective:
To evaluate the change in plasma levels of adiponectin and Asymmetric Dimethylarginine (ADMA) in type 2 diabetes patients after 12 weeks of treatment with Amaryl-M
Secondary Objectives:
- To assess the role of Amaryl-M in the change of plasma levels of adiponectin and ADMA in type 2 diabetes patients after 8 weeks of therapy
- To evaluate the brachial-ankle pulse wave velocity (baPWV) change after 8 and 12 weeks of therapy with Amaryl-M
- To evaluate the efficacy of Amaryl-M in the improvement of patients glycemic level (Fasting blood glucose (FBG) and glycosylated hemoglobin (HbA1c))
- To evaluate the change of Tumor Necrosis Factor - Alfa (TNF-Alfa) after 12 weeks of therapy with Amaryl-M
- To evaluate the Homeostatic Model Assessment of Insulin Resistance (HOMA-IR) change after 12 weeks of therapy with Amaryl-M
- To evaluate the HOMA-β change after 12 weeks of therapy with Amaryl-M
- To evaluate the relationship between adiponectin and ADMA level with FBG or HbA1c level
详细描述
The clinical trial will consist of 2 weeks of selection followed by a 12 weeks (3 months) of treatment period.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 40 Years 至 60 Years(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
Amaryl-M (Glimepiride + Metformin)
Experimental
Glimepiride 1 mg and metformin 250 mg are the active ingredients of Amaryl-M 1/250 mg film coated tablets.
Starting dosage is 1 tablet per day, then dosage titration will be based on the result of patient FBG test.
干预措施: GLIMEPIRIDE + METFORMIN (Drug)
结局指标
主要结局
Adiponectin and Asymmetric Dimethylarginine (ADMA) plasma level changes
时间窗: from baseline to end of Clinical Trial (12 weeks)
次要结局
- Change in adiponectin and Asymmetric Dimethylarginine (ADMA) plasma levels(at week 8)
- Pulse Wave Velocity (PWV) change(at week 8 and week 12)
- Change in Fasting Blood Glucose (FBG)(At week 2, 4, 8 and 12)
- Change in glycosylated hemoglobin (HbA1c)(at week 12)
- Change in Homeostatic Model Assessment of Insulin Resistance (HOMA-IR) and Homeostatic Model Assessment (HOMA-β)(At week 12)
- Change of Tumor Necrosis Factor- Alfa (TNF-Alfa)(At week 12)
研究者
研究点 (1)
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