inagliptin as a modulator of vascular inflammation in patients with type 2 diabetes mellitus - Lina-Plaque

RWTH Aachen University for the Medical Faculty, represented by Clinical Trial Center Aachen (CTC-A)0 个研究点目标入组 60 人开始时间: 2013年4月22日最近更新: 2015年12月7日

适应症

试验速览

暂无简介。

•- Diabetes mellitus Type 2
•- HbA1c > 7%
•- Age > 50 years
•- Coronary artery disease or carotid artery disease
•- 18F-FDG uptake of the carotid arterial wall to background (blood) ratio > 1.8
•- Written informed consent prior to study participation
•- Stable cholesterol lowering medication for the last 3 month
•- 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)
•- Indication to increase anti-diabetic medication as judged by the investigator
•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

•- Diabetes mellitus type 1
•- Use of DPP-4 Inhibitor and GLP-1 agonists
•- Liver disease (GPT or GOT > 3 times the upper limit of norm) or known liver cirrhosis
•- Any reason for not being able to sustain the imaging studies
•- Pacemaker/ICD/metallic clips in close relation to vessels in the brain
•- Uncontrolled thyroid disease
•- Active malignant disease of any kind with the exception of basalioma
•- Chronic inflammatory disease
•- Chronic use of NSAR or cortisone
•- HbA1c > 10%
•- Patients with a history of pancreatitis
•- Recent (< 6 weeks) clinically significant coronary or cerebral vascular event
•- Indication for coronary artery or cerebral vascular intervention in the next 6 month
•- Pregnant females as determined by positive [serum or urine] hCG test at Screening or prior to dosing
•- Lactating females
•- 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.
•- The subject received an investigational drug within 30 days prior to inclusion into this study
•- 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
•- The subject is unwilling or unable to follow the procedures outlined in the protocol
•- The subject is mentally or legally incapacitated

发起方

RWTH Aachen University for the Medical Faculty, represented by Clinical Trial Center Aachen (CTC-A)