NCT00939939终止4 期
Effect of Sitagliptin on Postprandial Lipoprotein Metabolism
适应症
干预措施
相关药物
试验速览
- 阶段
- 4 期
- 状态
- 终止
- 入组人数
- 3
- 试验地点
- 1
- 主要终点
- incremental area under the triglyceride curve (iAUC-TG)
研究概览
简要总结
The goal of the study is to evaluate whether sitagliptin can affect postprandial lipoprotein metabolism in type 2 diabetic patients.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 19 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •type 2 diabetes
- •dietary therapy
排除标准
- •lipid-lowering therapy
- •anti-hyperglycemic drug therapy
研究组 & 干预措施
sitagliptin
Experimental
干预措施: sitagliptin (Drug)
glimepirid
Active Comparator
干预措施: glimepiride (Drug)
结局指标
主要结局
incremental area under the triglyceride curve (iAUC-TG)
时间窗: 10 weeks
incremental area under the plasma triglyceride concentration curve following a standardized oral fat challenge
次要结局
- LDL-cholesterol(10 weeks)
- HDL-cholesterol(10 weeks)
- VLDL-cholesterol(10 weeks)
- triglycerides(10 weeks)
- area under the triglyceride curve (AUC-TG)(10 weeks)
- area under the VLDL-triglyceride curve (AUC-VLDL-TG)(10 weeks)
- incremental area under the VLDL-triglyceride curve (iAUC-VLDL-TG)(10 weeks)
- glucose(10 weeks)
- insulin(10 weeks)
- HOMA(10 weeks)
- HbA1c(10 weeks)
- interleukin-6(10 weeks)
- hs-CRP(10 weeks)
研究者
研究点 (1)
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The effect of sitagliptin on postprandial lipoprotein metabolism in patients with diabetes mellitus type 2Diabetes mellitus type 2MedDRA version: 9.1Level: LLTClassification code 10012613Term: Diabetes mellitus non-insulin-dependentMedDRA version: 9.1Level: LLTClassification code 10012619Term: Diabetes mellitus poor controlMedDRA version: 9.1Level: LLTClassification code 10045242Term: Type II diabetes mellitusMedDRA version: 9.1Level: LLTClassification code 10063624Term: Type II diabetes mellitus inadequate controlEUCTR2007-007805-58-DEMed. Klinik II, Grosshadern, Klinikum der Universität München
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