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

Sponsor

Johann Wolfgang Goethe University Hospital (Other)

Overall Status

Withdrawn

CT.gov ID

NCT00936234

Collaborator

(none)

Enrollment

Location

Arms

Duration (Months)

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
SDF-1 is an Important Cytokine for Neovascularization. Cleavage of SDF-1 is Reduced by DPPIV Inhibitors	Drug: Vildagliptin	Phase 2/Phase 3

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.

Study Design

Study Type:

Interventional

Actual Enrollment :

0 participants

Allocation:

Randomized

Intervention Model:

Crossover Assignment

Masking:

Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

Primary Purpose:

Basic Science

Official Title:

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

Study Start Date :

Jul 1, 2009

Actual Primary Completion Date :

Sep 1, 2011

Actual Study Completion Date :

May 1, 2013

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: Vildagliptin starting with vildagliptin for 30 days followed by placebo for 30 days	Drug: Vildagliptin Vildagliptin, 50 mg twice a days, orally for 30 days followed by placebo Other Names: Galvus (R)
Placebo Comparator: Placebo starting with placebo for 30 days followed by vildagliptin for 30 days	Drug: Vildagliptin Vildagliptin, 50 mg twice a days, orally for 30 days followed by placebo Other Names: Galvus (R)

Arm

Intervention/Treatment

Active Comparator: Vildagliptin

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

Drug: Vildagliptin

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

Other Names:

Galvus (R)

Placebo Comparator: Placebo

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

Drug: Vildagliptin

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

Other Names:

Galvus (R)

Outcome Measures

Primary Outcome Measures

Endothelial Function [30 days]

Secondary Outcome Measures

Number and Function of Progenitor Cells [30 days]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 80 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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