Off taRget Effects of Linagliptin monothErapy on Arterial Stiffness in Early Diabetes (RELEASE)

Inclusion Criteria:

• Men and women, age 30 to 70 years, AND
• Treatment naïve type 2 diabetes, as defined as t
• Fasting plasma glucose ≥ 7.0 mmol/l, OR
• Random plasma glucose ≥ 11.1 mmol/l, OR
• HbA1c ≥6,5%
• Written informed consent
• Assessable Pulse Wave Velocity measurement at screening

Exclusion Criteria:

• Current or previous use of glycemic control medications
• Type 1 diabetes
• Gestational diabetes mellitus
• Other specific types of diabetes due to other causes, e.g., genetic defects in β-cell function, genetic defects in insulin action, diseases of the exocrine pancreas (such as cystic fibrosis), and drug- or chemical-induced (such as in the treatment of HIV/AIDS or after organ transplantation)
• 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, triglycerides >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