Differences in endothelial function amongst Sitagliptin and Liraglutide Users: A randomized, open-label, parallel-group and active controlled trial

INTERVENTION: Trade Name: Liraglutide (Victoza®) Pharmaceutical Form: Solution for injection INN or Proposed INN: LIRAGLUTIDE CAS Number: 204656‐20‐2 Concentration unit: mg/ml milligram(s)/millilitre Concentration type: equal Concentration number: 6‐ Trade Name: Sitagliptin (Januvia®) Pharmaceutical Form: Tablet INN or Proposed INN: S/N CAS Number: 654671‐77‐9 Current Sponsor code: S/N Other descriptive name: SITAGLIPTIN PHOSPHATE MONOHYDRATE Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 25‐ CONDITION: Therapeutic area: Diseases [C] ‐ Nutritional and Metabolic Diseases [C18] type 2 diabetes patients not well controlled at the maximum tolerated dose of metformin PRIMARY OUTCOME: Main Objective: To assess the effects on endothelial function of a three month treatment with Liraglutide compared to Sitagliptin Primary end point(s): The primary endpoint will be comparing the baseline corrected change in endothelial function by flow‐mediated vasodilation (FMD) of the brachial artery at 3 months between the treatment arms Secondary Objective: To assess the effects of a three month treatment with Liraglutide compared to Sitagliptin on other emerging potential cardiovascular risk factors, such as oxidative stress markers, cytokines, and soluble cell adhesion molecules.; To compare the safety profile of both treatment groups. Timepoint(s) of evaluation of this end point: Twice: Baseline (To be assessed before first treatment administration) and week 12 SECONDARY OUTCOME: Secondary end point(s): The secondary endpoints will include comparing the baseline corrected change of the following cardiovascular risk factors at 3 months between the treatment arms:; Serum biomarkers: apolipoprotein A1, apolipoprotein B, levels of oxidized low‐density lipoprotein (ox‐LDL), soluble vascular cell adhesion molecule (VCAM), high sensitive C‐reactive protein (hsCRP), interleukin 6 (IL‐6); Measures of oxidative stress: nitrotyrosine, urinary free 8‐iso prostaglandin F2 alpha (8‐iso PGF2alpha) ; Global measure of glucose instability, particularly of postprandial hyperglycemia: 1,5‐anhydroglucitol ; Lipids: Plasma total cholesterol, plasma high density lipoprotein‐cholesterol (HDL‐cholesterol), direct plasma low density lipoprotein‐cholesterol (LDL‐cholesterol), plasma triglyceride levels, free fatty acids; Weight; Systemic blood pressure; Glycemic control parameters: fasting glucose, fasting insulin, haemoglobin A1c (HbA1c), 7 point glucose self monitored Timepoint(s) of evaluation of this end point: Serum biomarkers, Measures of oxidative stress and Glycemic control parameters: Twice, Baseline (To be assessed before first treatment administration) and week 12. ; Weight, Systemic blood pressure and Lipids: 3 times, screening visit, baseline and week 12. INCLUSION CRITERIA: 1.Informed consent obtained before any trial‐related activities. (Trial‐related activities are any procedure that would not have been performed during normal management of the subject.) 2.Male or female patients between 45 and 65 years old 3.Pre‐existing type 2 diabetes with HbA1c between 7.0 and 9.5% 4.Triglycerides >1.68 mmol/L 5.HDL cholesterol <1.29 mmol/L in women and <1.04 mmol/L in men 6.Systolic blood pressure (SBP) <130 mmHg and diastolic blood pressure (DBP) <85 mmHg or treatment with antihypertensive agents 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 60 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 60