Doppelblinde, randomisierte Placebo-kontrollierte crossover-Studie zur Erfassung des Effektes einer DPP-IV-Hemmung auf die Zahl und Funktion von Progenitorzellen sowie die Endothelfunktion von Patienten mit Diabetes mellitus Functional Improvement of Progenitor Cells and Endothelial Function by Vildagliptin in Diabetes Mellitus - FINNjA-DM

INTERVENTION: Trade Name: Galvus Pharmaceutical Form: Tablet INN or Proposed INN: Vildagliptin Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 50‐ Pharmaceutical form of the placebo: Tablet Route of administration of the placebo: Oral use CONDITION: Patients with stable diabetes mellitus typ 2 and HbA1c between 7,0% and 10,0% PRIMARY OUTCOME: Main Objective: improvement of endothelial function Primary end point(s): improvement of endothelial function at the vildagliptin group after 4 weeks ‐ measured in vivo with venous Occlussionsplethysmography Secondary Objective: safety of vildagliptin; number and functional activity of progenitor cells; INCLUSION CRITERIA: male and female patients with diabetes mellitus type 2 under stable medication, age from 18 to 80 years, HbA1c between 7% an 10%, Signed informed consent, female patients using contraceptions 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 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range