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

Dekan des Fachbereichs Medizin der Johann Wolfgang Goethe-Universität Frankfurt/M.0 个研究点开始时间: 2009年4月14日最近更新: 2013年5月20日

适应症

试验速览

暂无简介。

•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

发起方

Dekan des Fachbereichs Medizin der Johann Wolfgang Goethe-Universität Frankfurt/M.