Patients with stable diabetes mellitus typ 2 and HbA1c between 7,0% and 10,0%
Conditions
Interventions
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 plac
Sponsors
Dekan des Fachbereichs Medizin der Johann Wolfgang Goethe-Universität Frankfurt/M.
Eligibility
Sex/Gender
All
Inclusion criteria
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
Exclusion criteria
Exclusion criteria: Atrial fibrillation (plethysmographic recordings can only obtained in sinus-rhythm), CAD with reduced left ventricular ejection fraction (LVEF 2,5 mg/dl) on the timepoint of treatment Severe liver (GOT > 2x of upper norm value or spontaneous INR > 1,5), HIV infection or aktive Hepatitis Anaemia (Hb <10 mg/dl) Thrombocytopenia < 100.000/µl Participation at other studies within the last 30 days mental retardation any condition that in the opinion of the investigator increases the risk for the patient or excludes the adequat analysis of study data
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: improvement of endothelial function;Secondary Objective: safety of vildagliptin number and functional activity of progenitor cells ;Primary end point(s): improvement of endothelial function at the vildagliptin group after 4 weeks - measured in vivo with venous Occlussionsplethysmography | — |
Countries
Germany
Outcome results
None listed