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临床试验/NCT01204580
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)

Sanofi1 个研究点 分布在 1 个国家目标入组 40 人开始时间: 2010年12月最近更新:
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:

  1. 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
  2. To evaluate the brachial-ankle pulse wave velocity (baPWV) change after 8 and 12 weeks of therapy with Amaryl-M
  3. To evaluate the efficacy of Amaryl-M in the improvement of patients glycemic level (Fasting blood glucose (FBG) and glycosylated hemoglobin (HbA1c))
  4. To evaluate the change of Tumor Necrosis Factor - Alfa (TNF-Alfa) after 12 weeks of therapy with Amaryl-M
  5. To evaluate the Homeostatic Model Assessment of Insulin Resistance (HOMA-IR) change after 12 weeks of therapy with Amaryl-M
  6. To evaluate the HOMA-β change after 12 weeks of therapy with Amaryl-M
  7. 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

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

发起方
Sanofi
申办方类型
Industry
责任方
Sponsor

研究点 (1)

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