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临床试验/NCT01262586
NCT01262586已完成3 期

Pilot Study to Assess the Difference in Glycemic Profiles Between Vildagliptin and Glimepiride Using Continuous Glucose Monitoring Device

Novartis Pharmaceuticals1 个研究点 分布在 1 个国家目标入组 24 人开始时间: 2010年11月最近更新:
适应症
干预措施
相关药物

试验速览

阶段
3 期
状态
已完成
入组人数
24
试验地点
1
主要终点
Change in Glycemic profiles between vildagliptin and glimepiride

研究概览

简要总结

This study will use Continuous Glucose Monitoring to assess differences in glycemic profiles between vildagliptin and glimepiride.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Crossover
主要目的
Treatment
盲法
None

入排标准

年龄范围
18 Years 至 70 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Type 2 diabetes patients on stable metformin
  • 18-70 years old
  • Willing to perform at least 4 capillary blood glucose tests per day

排除标准

  • Type 2 diabetes patients on any other antidiabetic treatment
  • Patients listed in other trials
  • Patients with significant diabetic organ disease or complications.
  • Other protocol-defined inclusion/exclusion criteria may apply

研究组 & 干预措施

Vildagliptin

Experimental

干预措施: Vildagliptin (Drug)

Glimepiride

Active Comparator

干预措施: Glimepiride (Drug)

结局指标

主要结局

Change in Glycemic profiles between vildagliptin and glimepiride

时间窗: Baseline and treatment Day 5, 24hr continuous glucose measurements

次要结局

  • Glucose Fluctuation before and during treatment(Baseline and treatment Day 5, 24hr continuous measurements)

研究者

申办方类型
Industry
责任方
Sponsor

研究点 (1)

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