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

NCT00936234 | Withdrawn Phase 2 DMC

• 1 other identifier: FINNjA-DM
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

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.

Conditions

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

Keywords

CAD; diabetes; SDF-1; endothelial function

Outcome Measures

Primary Outcomes (1)

• Endothelial Function

  30 days

Secondary Outcomes (1)

• Number and Function of Progenitor Cells

  30 days

Study Arms (2)

Vildagliptin

ACTIVE COMPARATOR

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

Drug: Vildagliptin

Placebo

PLACEBO COMPARATOR

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

Drug: Vildagliptin

Interventions

Vildagliptin DRUG

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

Also known as: Galvus (R)

Placebo; Vildagliptin

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients with diabetes mellitus type 2 under stable medication
• HbA1c between 7% an 10%
• age between 18 and 80 years
• signed informed consent

You may not qualify if:

• 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

Sponsors & Collaborators

• Johann Wolfgang Goethe University Hospital: lead

Study Sites (1)

Department of Cardiology

Frankfurt, 60590, Germany

Location

MeSH Terms

Conditions

Diabetes Mellitus

Interventions

Vildagliptin

Condition Hierarchy (Ancestors)

Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Intervention Hierarchy (Ancestors)

Nitriles; Organic Chemicals; Pyrrolidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Study Officials

• Andreas M. Zeiher, MD

  Cardiology, University of Frankfurt

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: BASIC SCIENCE
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Prof. Dr.

Study Record Dates

• First Submitted: July 8, 2009
• First Posted: July 9, 2009
• Study Start: July 1, 2009
• Primary Completion: September 1, 2011
• Study Completion: May 1, 2013
• Last Updated: September 2, 2020

Record last verified: 2020-08

Locations

DE (1)