Off taRget Effects of Linagliptin monothErapy on Arterial Stiffness in Early diabetes - RELEASE

niversity Medical Center Groningen0 个研究点开始时间: 2013年5月17日最近更新: 2016年5月9日

适应症

试验速览

暂无简介。

•- Men and women, age 30 to 70 years, AND
•- Treatment naïve type 2 diabetes, as defined as the presence of one of the following (American Diabetes Association definition:
•- Fasting plasma glucose = 7.0 mmol/l, OR
•- Random plasma glucose = 11.1 mmol/l, OR
•- HbA1c =6,5%
•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 40
•F.1.3 Elderly (>=65 years) no
•F.1.3.1 Number of subjects for this age range

•- Current or previous use of glycemic control medications
•- Type 1 diabetes
•- Gestational diabetes mellitus
•- Other specific types of diabetes due to other causes
•- Uncontrolled hypertension, defined as systolic blood pressure >160 or a diastolic blood pressure >100 mmHg at screening visit
•- Severe dyslipidemia indicating primary dyslipidemia, defined as total cholesterol >8 mmol/l, tryglicerides >10 mmol/l of high density lipoprotein cholesterol <0.6 mmol/l
•- Current use of weight loss medication or previous weight loss surgery
•- History of severe gastrointestinal disease
•- Clinical contraindications to DPP4-inhibitors
•- Previous cardiovascular disease, defined as stable coronary artery disease or acute coronary syndrome, stroke or transient ischemic attack, peripheral artery disease
•- Symptomatic heart failure, New York Heart Association (NYHA) class II-IV
•- Women who are currently pregnant,planning to become pregnant,breastfeeding women, or women with child bearing potential not using appropriate contraceptive measures
•- Clinically significant liver disease or hepatic function greater than 3 times upper limit of normal
•- Known impaired renal function or eGFR <30 ml/min/1.73m2
•- Patients who are mentally incompetent and cannot sign a Patient Informed Consent
•- Current active malignancy or in the previous 6 months
•- Documented HIV infection
•- Use of rifampicin

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