Effect of Vildagliptin vs. Glibenclamide on Circulating Endothelial Progenitor Cell Number Type 2 Diabetes

Inclusion Criteria

• Age equal or above 35 years;
• Diagnosis of type 2 diabetes mellitus as defined by the American Diabetes Association , with at least one year of disease duration at the time of the screening visit;
• Blood glucose lowering treatment with Metformin alone (monotherapy) at a stable dose of at least 1.5 g/day (or maximum tolerated dose) in the 3 months prior to the screening visit;
• Insufficient metabolic control as defined by recent (last six months) HbA1c ≥ 7% in any peripheral laboratory and confirmed at the time of the screening;
• Absence of a recent clinically-relevant progression of micro- and macro-vascular complications (see exclusion criteria);
• Written informed consent to participate to the study.

Exclusion criteria

• Age below 35 years
• Type 1 diabetes or other causes of diabetes (pancreatectomy, gestational diabetes, etc.)
• HbA1c 190 or Diastolic Blood Pressure (DBP) >100 mmHg)
• Ongoing pregnancy or absence of effective contraception in women with childbearing potential
• Contraindications to the maintenance of the background therapy (Metformin), including -but not limited to- chronic kidney failure or plasma creatinine concentrations > 1.5 mg/dL, severe respiratory failure, etc.;
• Contraindications to the use of a Sulfonylurea;
• Contraindications to the use of a DPP-IV Inhibitor;
• Laboratory findings, or other disease conditions, at the screening visit that might interfere with study measurements:
• Hemoglobinopathy known to affect HbA1c assays;
• Known chronic liver diseases, including HBV (hepatitis B virus) and HCV (hepatitis C virus) infection;
• Liver makers (aspartate transaminase (AST), alanine aminotransferase (ALT), alkaline phosphatase (ALP), Gamma-glutamyltransferase (GGT) , bilirubin) above 2 times the upper normal limit;
• Amylase and/or lipase above 2 times the upper normal limit;
• Chronic use of systemic and/or inhaled corticosteroids (only topical corticosteroids are allowed);
• History of low compliance, clinically-relevant psychiatric disorders or any current/ historical finding suggesting the patient as inappropriate to follow the study procedures.