EUCTR2016-003253-15-NL进行中(未招募)1 期
MODULATION OF POSTPRANDIAL LIPEMIA, INFLAMMATION, AND VASCULAR FUNCTION BY PCSK9 INHIBITION IN DIABETES. - PLEIADES-pcsk9
Franciscus Gasthui0 个研究点开始时间: 2017年1月3日最近更新:
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中(未招募)
- 发起方
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- Male
入选标准
- •- Age of 18 years or older
- •- Fasting triglycerides levels between 1.8 mmol/L and 7.0 mmol/L
- •- Diabetes mellitus type 2 on intensive insulin treatment (three times short acting and one daily long acting) (unchanges for >10 weeks prior to consent)
- •- Stable glucose regulation last 6 months (HbA1c >6.5% - < <9.0%)
- •- Stable lipid lowering therapy last 2 months (no changes in regiments or dose)
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 20
- •F.1.3 Elderly (>=65 years) no
- •F.1.3.1 Number of subjects for this age range
排除标准
- •- Current smoking
- •- Impaired renalfunction (MDRD <60 ml/min/1.73 m2)
- •- Recent cardiovascular event (<6 months) (myocardial infarction, coronary artery bypass grafting, stroke)
- •- Severe hyperglycemic events in the past 6 months (hyperglycemia >20 mmol/L requiring hospital admittance)
- •- Recent or current use of pcsk9 antibodies
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