EUCTR2012-003858-81-DE进行中（未招募）1 期
Effect of Linagliptin therapy on myocardial diastolic function in patients with type 2 diabetes mellitus - Diastolic Dysfunction
RWTH Aachen, Medizinische Fakultät0 个研究点目标入组 60 人开始时间: 2013年4月22日最近更新:
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
- 60
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.Diabetes mellitus Type 2
- •2.Age > 18 years
- •3.HbA1c > 7%
- •4.Left ventricular diastolic dysfunction determined by echocardiography as é < 8 in addition to
- •-E/A < 0.8 (Grade I) or
- •-E/A 0.8-2 and left atrial volume = 34 ml/m2 (Grade II) or
- •-E/A = 2 (Grade III)
- •5.Stable anti-diabetic medication for the last 6 weeks which should include a maximal tolerated dose of metformin (unless contraindication or intolerance to metformin does exist)
- •6.Indication to increase anti-diabetic medication as judged by the investigator
- •7.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 20
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 40
排除标准
- •Subjects, fulfilling one or more of the following exclusion criteria will not be included in the study:
- •1.Diabetes mellitus type 1
- •2.Echocardiography:
- •-decreased left ventricular systolic function, ejection fraction (EF) <45%
- •-regional wall motion abnormalities
- •-Hypertrophic cardiomyopathy (septum >15mm)
- •-Severe valvular dysfunction
- •3.Uncontrolled hypertension
- •4.Paroxysmal atrial fibrillation during the last two months
- •5.Use of DPP-4 Inhibitor (Dipeptidyyl-peptidase IV Inhibitor), GLP-1 agonists
- •6.Liver disease (ALT or AST > 3 times the upper limit of norm) or known liver cirrhosis
- •7.Active malignant disease
- •8.HbA1c > 10%
- •9.Recent (<6 weeks) clinically significant coronary or cerebral vascular event, current angina pectoris or ischemia on stress tests
- •10.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.
- •11.Lactating females
- •12.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.
- •13.The subject received an investigational drug within 30 days prior to inclusion into this study
- •14.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
- •15.The subject is unwilling or unable to follow the procedures outlined in the protocol
- •16.The subject is mentally or legally incapacitated
- •17. Patients with a history of pancreatitis
研究者
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