Endothelial Effects of Basal Insulin: Detemir Versus Glargine
Endothelial progenitor cell (EPC) level represents a surrogate marker of cardiovascular risk and an indicator of the ongoing vascular damage. Moreover, EPCs are involved in the pathogenesis of virtually all diabetic complications. Therefore, ways to modulate EPCs are currently considered of utmost importance, especially in high-risk subjects. While many drugs with pleiotropic vasculoprotective effects have shown ability to positively modulate EPCs, there is no data on the effects of specific insulin formulations.
This is a human randomised cross-over comparison trial. The purpose is to compare the effects of two basal insulin analogues (detemir and glargine) added to oral antidiabetic therapy in poorly-controlled type 2 patients with cardiovascular disease on endothelial function and EPC levels.
The aim is to test whether optimized glycemic control with add-on basal insulin analogues improves endothelial damage and regeneration in type 2 diabetes with macroangiopathy and to compare the effects of glargine vs detemir on markers of endothelial damage and regeneration.
EPC level is the most innovative outcome measure of this study and represents the primary endpoint. Endothelial dysfunction/damage, evaluated using soluble markers, will be the secondary outcome. Given the supposed inverse correlation between EPC and endothelial damage, it is expected that EPC increase reflects amelioration in endothelial biology, a result that may have significant clinical implications in this cohort of high-risk patients.
Type 2 Diabetes
|Study Design:||Allocation: Randomized
Endpoint Classification: Pharmacodynamics Study
Intervention Model: Crossover Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||Effects of Optimized Glycemic Control Achieved With add-on Basal Insulin Therapy on Indexes of Endothelial Damage and Regeneration in Type 2 Diabetic Patients With Macroangiopathy. A Randomized Cross-over Trial Comparing Detemir vs Glargine|
- Change in endothelial progenitor cell count [ Time Frame: Basal, 3 months, 6 months ] [ Designated as safety issue: No ]
- Change in markers of endothelial damage [ Time Frame: Basal, 3 months, 6 months ] [ Designated as safety issue: No ]
- Frequence of hypoglycemias [ Time Frame: during 1st and 2nd arms ] [ Designated as safety issue: Yes ]The frequency of hypoglycemia will be reported for patients on glargine or detemir during the 1st and 2nd period of treatment.
- Change in body weight [ Time Frame: After the 1st and 2nd arms ] [ Designated as safety issue: Yes ]Change in body weight will be assessed after each arm during treatment with glargine or detemir
|Study Start Date:||May 2008|
|Study Completion Date:||March 2010|
|Primary Completion Date:||March 2010 (Final data collection date for primary outcome measure)|
Active Comparator: Glargine
During this arm/phase patients take subcutaneous glargine daily for 3 months.
Daily bedtime subcutaneous insulin Glargine in individualized doses.
Other Name: Lantus
During this arm/phase, patients take insulin Detemir subcutaneously for 3 months.
Daily bedtime subcutaneous insulin Detemir in individualized doses.
Other Name: Levemir
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|Dipartimento di Medicina Clinica e Sperimentale, Divisione di Malattie del Metabolismo|
|Padova, Italy, 35100|
|Principal Investigator:||Angelo Avogaro, M.D.||University of Padova, Medical School|