drugset / Trial / NCT00523393

Prospective Influence of Bedtime Insulin Glargine on Mobilization and Function of Endothelial Progenitor Cells

NCT00523393

Phase 4 Unknown 75 enrolled Heidelberg University
RandomizedParallel-groupQuadruple-blindPrevention

Summary

In this trial, it will be studied whether early addition of the long acting insulin analogue Glargine is capable of increasing the number and differentiation of endothelial progenitor cells (EPC) in patients with type 2 diabetes, which can be seen as a marker of vascular regenerative potential and cardiovascular risk. In addition, the effect of Glargine on microvascular function will be studied. This will be done using laser Doppler measurements of the skin; in addition, MRI of the heart will be performed which is capable of quantifying the perfusion reserve of the myocardium and additional functional aspects of ventricular function. A beneficial effect of early addition of bedtime Glargine on EPC and vascular as well as myocardial function in this study might argue for a change in the therapeutic approach in type 2 diabetes and possibly improve the cardiovascular outcome in patients affected.

Timeline

Start
2007-08
Primary completion
2009-12
Completion
2010-05

Drugs

EvaluationDrugModalityDoseRoute
Comparator Insulin Protein / enzyme biologic
Subject Insulin Glargin Protein / enzyme biologic