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

NCT ID: NCT00936234

Last Updated: 2020-09-02

Basic Information

• Recruitment Status: WITHDRAWN
• Clinical Phase: PHASE2/PHASE3
• Study Classification: INTERVENTIONAL
• Study Start Date: 2009-07-31
• Study Completion Date: 2013-05-31

Brief 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.

Detailed Description

The peptidase CD26 (DPPIV/dipeptidyl peptidase IV) removes dipeptides from the amino terminus of proteins and thereby inactivates these cleaved proteins. It was shown, that CD26 cleaves SDF-1 into a non-mitogenic molecule. Inhibition or deletion of CD26 leads to an increased homing of hematopoietic progenitor cells to the bone marrow after transplantation by increasing the invasion capacity of these cells {Campbell et al. 2008; Christopherson et al. 2004}.

The cytokine SDF-1 is released in response to hypoxia, is crucial for progenitor cell homing and recruitment of cells for neovascularisation. Invasion capacity is closely related to the cytokine SDF-1 and the SDF-1 receptor CXCR4 {Ceradini et al. 2004}. The in vivo neovascularisation capacity of progenitor cells is closely correlated to their functional capacity as SDF-1 induced invasion or colony-forming capacity {Heeschen et al. 2004; Britten et al. 2003; Assmus et al. 2007}.

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

Conditions

SDF-1 is an Important Cytokine for Neovascularization. Cleavage of SDF-1 is Reduced by DPPIV Inhibitors

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: BASIC_SCIENCE
• Blinding Strategy: QUADRUPLE

Study Groups

Vildagliptin

starting with vildagliptin for 30 days followed by placebo for 30 days

Group Type: ACTIVE_COMPARATOR

Vildagliptin

Intervention Type: DRUG

Vildagliptin, 50 mg twice a days, orally for 30 days followed by placebo

Placebo

starting with placebo for 30 days followed by vildagliptin for 30 days

Group Type: PLACEBO_COMPARATOR

Vildagliptin

Intervention Type: DRUG

Vildagliptin, 50 mg twice a days, orally for 30 days followed by placebo

Interventions

Vildagliptin

Vildagliptin, 50 mg twice a days, orally for 30 days followed by placebo

Intervention Type: DRUG

Other Intervention Names

Galvus (R)

Eligibility 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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Johann Wolfgang Goethe University Hospital

OTHER

Sponsor Role: lead

Responsible Party

Florian Seeger

Prof. Dr.

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Andreas M. Zeiher, MD

Role: PRINCIPAL_INVESTIGATOR

Cardiology, University of Frankfurt

Locations

Department of Cardiology

Frankfurt, , Germany

Countries

Germany

Other Identifiers

FINNjA-DM

Identifier Type: -

Identifier Source: org_study_id