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Table 1 Inclusion and exclusion criteria

From: Twelve-week randomized study to compare the effect of vildagliptin vs. glibenclamide both added-on to metformin on endothelium function in patients with type 2 diabetes and hypertension

Inclusion criteria

Exclusion criteria

Patients aged ≥35 years

Use of NPH or regular insulin, pioglitazone, GLP-1 receptor agonist, DPP-4 inhibitor or acarbose

History of DM and mild hypertension (blood pressure <160/100 mmHg) no longer than 15 years

Intolerance to metformin

Body mass index <35 kg/m2

Use of three or more anti-hypertensive drugs, which characterizes resistant hypertension

Glycated hemoglobin (HbA1c) between 7.0 and 10.5 %

Smoking within the previous 6 months

 

Pregnancy or breastfeeding

 

Creatinine clearance <45 mL/min (MDRD)

 

Serum alanine aminotransferase or aspartate aminotransferase level of more than three times the upper limit of the normal range

 

Subjects with ischemic heart disease, cerebrovascular disease, other atherosclerotic disease, cancer, or heart failure in functional classes II, III and IV

 

Treadmill stress test with typical chest pain or with ST segment depression ≥1 mm, or with a horizontal or descending trace on the electrocardiogram for a duration of 0.08 s after the J point

 

Presence of coronary heart disease diagnosed by treadmill stress test, myocardial scintigraphy or coronary angiography

 

Inability to give informed consent