EUCTR2017-005032-42-DE进行中（未招募）1 期
Effect of Liraglutide on the Metabolic Profile in Patients with Type 2 Diabetes and Cardiovascular Disease - Lirabolic
RWTH Aachen University represented by the Rector himself, represented by the Dean of the Medical Faculty0 个研究点目标入组 50 人开始时间: 2020年2月10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
- 入组人数
- 50
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
- All
入选标准
- •1. Type 2 diabetes
- •2. Serum levels of HbA1c = 7,0%
- •3. Age = 18 years
- •4. Patients with existing cardiovascular disease: coronary heart disease, cerebrovascular disease, peripheral vascular disease or chronic kidney disease of stage III or greater or chronic heart failure of NYHA II or III
- •5. Written informed consent prior to study participation
- •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 25
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 25
排除标准
- •1.Type 1 diabetes
- •2.Treatment with GLP-1 receptor agonists or DPP-4 inhibitors within in the last 4 weeks
- •3.Patients with familiar or personal history of multiple endocrine neoplasia-type 2 or medullary C-cell cancer
- •4.Renal impairment (eGFR < 30 mL/min)
- •5.Occurrence of acute vascular events within 6 weeks before screening and randomization
- •6.Known or suspected hypersensitivity to Liraglutide
- •7.Pregnant females as determined by positive [serum or urine] hCG test at Screening or prior to dosing. Participants of child-bearing age should use adequate contraception as defined in the study protocol.
- •8.Lactating females
- •9.The subject has a history of any other illness, which, in the opinion of the Investigator, might pose an unacceptable risk by administering study medication.
- •10.The subject received an investigational drug within 30 days prior to inclusion into this study.
- •11.The subject has any current or past medical condition and/or required medication to treat a condition that could affect the evaluation of the study.
- •12.The subject is unwilling or unable to follow the procedures outlined in the protocol.
- •13.The subject is mentally or legally incapacitated.
研究者
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