Liraglutide: Solution for subcutaneous injection 6 mg/ml; Flexpen 3 ml.
Dose: s.c. 0,6 mg (0,1 mL) once daily. After 1 week, the dose will be increased to 1,2 mg (0,2 mL) once daily. If tolerated, after 1 week, dose will be increased to 1.8 mg (0,3 mL) once daily. In case of a hypoglycaemic episode, the dosage of oral blood glucose lowering medicaments will be adjusted first. If hypoglycaemia persists, Liraglutide / Liraglutide placebo will be adjusted on the basis of clinical parameters.
Duration: 26 weeks

Liraglutide placebo: Solution for injection; Flexpen 3 ml.
Dosage: same as Liraglutide
Duration: 26 weeks

Diabetes Mellitus Type 2

Metabolic Syndrome

Cardiovascular Disease

Diastolic Dysfunction

Fatty Liver

Preparation and labelling of Investigational Medicinal Product:
Liraglutide will be packed and labeled by Novo Nordisk A/S and provided in non-subject specific boxes. Labeling will be in accordance with Annex 13, local law and trial requirements. The examples of labels are not readily available, but will be supplied when received from Novo Nordisk.
Drug accountability:
Drug accountability will be cared for by the Department of Clinical Pharmacy of the LUMC. The trial product will be dispensed to each subject as required according to treatment group by the clinical pharmacist. No trial product will be dispensed to any person not enrolled in the trial.

Liraglutide

Preparation and labelling of Investigational Medicinal Product:
Liraglutide - Placebo will be packed and labeled by Novo Nordisk A/S and provided in non-subject specific boxes. Labeling will be in accordance with Annex 13, local law and trial requirements. The examples of labels are not readily available, but will be supplied when received from Novo Nordisk.
Drug accountability:
Drug accountability will be cared for by the Department of Clinical Pharmacy of the LUMC. The trial product will be dispensed to each subject as required according to treatment group by the clinical pharmacist. No trial product will be dispensed to any person not enrolled in the trial.

Liraglutide - Placebo

Leiden University Medical Center

Effect of Liraglutide on Cardiovascular Endpoints in Diabetes Mellitus Type 2 Patients

Magnetic Resonance Assessment of Victoza Efficacy in the Regression of Cardiovascular Dysfunction In Type 2 Diabetes Mellitus

Change from baseline in ml: difference between groups

Change from baseline in percentage: difference between groups

Change from baseline in L/min: difference between groups

Change from baseline in L/min/m2: difference between groups

Change from baseline in ml end-diastolic volume/sec: difference between groups

Change from baseline in ml/sec: difference between groups

Change from baseline of the ratio: difference between groups

Change from baseline in cm/sec: difference between groups

Change from baseline in mmHg: difference between groups

Change from baseline of total vessel wall area in mm2: difference between groups

Change from baseline of average vessel wall thickness in mm: difference between groups

Change from baseline of a minimum vessel wall thickness in mm: difference between groups

Change from baseline of maximum vessel wall thickness in mm: difference between groups

Change from baseline of vascular distensibility (pulse wave velocity): difference between groups

Change from baseline of the ratio subcutaneous fat / visceral abdominal fat: difference between groups

Change from baseline of total fat volume in ml: difference between groups

Change from baseline in cm3: difference between groups

Measurements will be used to guide therapeutic management
The outcome measure glycemic control will be based on the average HBA1C level of all measurements and regards: difference between groups.

Fasting blood glucose levels will be used to guide therapeutic management and for safety reasons.
Outcome measure: the difference between groups of the average of all measurements.

Change from baseline of myocardial T1 - values before and after contrast: difference between groups

Length, body weight and calculated BMI.
Outcome measure: Change from baseline in kg (body weight) or kg/m2 (BMI): difference between groups

Waist circumference divided by hip circumference.
Outcome measure: change from baseline: difference between groups

Measurements for routine clinical management
Outcome measure: change from baseline in mmHg: difference between groups

Change from baseline: difference between groups
Measurement with indirect calorimetry (Jaeger, OxyconPro)

Fluorescence-Activated Cell Sorting (FACS).
Change from baseline: difference between groups.

Peripheral Blood Mononuclear Cell isolation to analyze immunological activation and status of subjects. Both quantification of white blood cells (T-cells, B-cells, macrophages) and functional analysis will be performed.
Change from baseline: difference between groups

Change from baseline: difference between groups

Cholesteryl ester transfer protein
Change from baseline: difference between groups

Quantitative Insulin Sensitivity Check Index
Change from baseline: difference between groups

Change from baseline of urinary albumin / creatinine ration: difference between groups

Immunological status as assessed by RNA profiling. Change from baseline: difference between groups

Metabolomics in urine and blood sample. Change from baseline: difference between groups

Total daily dose (units) of insulin. Change from baseline: difference between groups

Number of grade 1, 2 and 3 hypoglycaemic episodes as detected with self measurement by participants. Comparison between groups.

diacylglycerol/infarction

Effect of Liraglutide on Cardiovascular Endpoints in Diabetes Mellitus Type 2 Patients

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