Endothelial Effects of Basal Insulin: Detemir Versus Glargine

• Status: Completed
• Trial end date: 2010-03-01
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: University of Padova
• Treatments: Insulin; Insulin Detemir; Insulin Glargine; Insulin, Globin Zinc

Criteria

Inclusion Criteria:

• Type 2 diabetes

• Macroangiopathy (coronary, or peripheral, or cerebrovascular)

• On oral antidiabetic therapy

• HbA1c > 7.0%

Exclusion Criteria:

• Type 1 diabetes

• Acute diabetic decompensation

• Use of glitazones

• Cancer

• Acute disease or infection

• Chronic renal failure (serum creatinin > 2.0 mg/dl)

• Advanced liver disease (Child B-C)

• Immune disease, organ transplantation, immunosuppression

• Recent surgery (within 3 months)

• Recent cardiovascular events (within 3 months)

• Inability to provide informed consent

• Pregnancy and lactation