Functional Improvement of Progenitor Cells and Endothelial Function by Vildagliptin in Diabetes Mellitus (FINNjA-DM).

• Status: Withdrawn
• Trial end date: 2013-05-01
• Target enrollment: 0
• Participant gender: All

Summary

SDF-1, an important cytokine for neovascularisation is cleaved by (dipeptidyl peptidase IV) DPPIV.

The aim of this study is to assess the effect of the dipeptidyl peptidase IV inhibitor vildagliptin (Galvus®) on endothelial function as well as number and functional activity of progenitor cells in patients with documented diabetes mellitus.

• Phase: Phase 2/Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Johann Wolfgang Goethe University Hospital
• Treatments: Vildagliptin

Criteria

Inclusion Criteria:

• Patients with diabetes mellitus type 2 under stable medication

• HbA1c between 7% an 10%

• age between 18 and 80 years

• signed informed consent

Exclusion Criteria:

• Atrial fibrillation (plethysmographic recordings can only obtained in sinus-rhythm)

• CAD with reduced left ventricular ejection fraction (LVEF <45%)

• Pregnancy, chronic or acute infection, fever

• Diabetes mellitus type 1

• Newly diagnosed diabetes, uncontrolled diabetes

• Neoplasm

• Known allergy to study drug

• Severe liver/kidney disease

• HIV, Hepatitis

• Participation at other studies within the last 30 days