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 mellitusFunctional Improvement of Progenitor Cells and Endothelial Function by Vildagliptin in Diabetes Mellitus - FINNjA-DM
- Conditions
- Patients with stable diabetes mellitus typ 2 and HbA1c between 7,0% and 10,0%
- Registration Number
- EUCTR2008-007667-17-DE
- Lead Sponsor
- Dekan des Fachbereichs Medizin der Johann Wolfgang Goethe-Universität Frankfurt/M.
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- Not specified
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
Atrial fibrillation (plethysmographic recordings can only obtained in sinus-rhythm),
CAD with reduced left ventricular ejection fraction (LVEF <45%),
Pregnancy and breast-feeding
acute infection or fever,
chronic infections like M. Crohn, Rheumatoide Athritis
Diabetes mellitus type 1,
Newly diagnosed diabetes type 2,
uncontrolled diabetes type 2,
Neoplasm without documented complete remission in the last 5 years,
Known allergy or intolerance to study drug (vildagliptin), lidocain or vasodilatators
apoplectic insult in the last 3 month,
kidney disease (Kreatinin > 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
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Main Objective: improvement of endothelial function;Secondary Objective: safety of vildagliptin<br>number and functional activity of progenitor cells<br>;Primary end point(s): improvement of endothelial function at the vildagliptin group after 4 weeks - measured in vivo with venous Occlussionsplethysmography
- Secondary Outcome Measures
Name Time Method