Effects on Re-endothelialisation With Bydureon Treatment in Type 2 Diabetes Subjects — Rebuild  

Diabetes Clinical Trial

Official title: Effects on Re-endothelialisation With Bydureon Treatment Add on to Insulin Versus Insulin Alone, Both in Combination With Metformin in Type 2 Diabetic Subjects

Status Completed

Clinical Trial Summary

The aim of the study is to use Exenatide long-acting release (LAR) [Bydureon] to minimize vascular remodeling and neointima formation after Percutaneous Coronary Intervention (PCI) and to accelerate stent endothelialisation.

Clinical Trial Description

Exenatide LAR will be given as a once-weekly (s.c.) dose of Bydureon (2 mg) add on to Insulin in combination with Metformin. If patients are Insulin naïve (both groups) an initial dose of 10U (s.c.) at bedtime will be started, and further up-titrated to achieve a fP-glucose levels at 6 mmol/l. Standard care for post myocardial infarction will be given after PCI.

Primary objectives:

To test whether Bydureon, add on to Insulin Neutral Protamine Hagedorn (NPH) + Metformin, is superior vs. Insulin NPH + Metformin alone, in covered stent struts

Secondary objectives:

To test whether Bydureon, add on to Insulin NPH + Metformin, is superior vs. Insulin NPH + Metformin alone: in cardiac and endothelial functions ;

Related Conditions & MeSH terms

• Atherosclerosis
• Diabetes
• Restenosis

• NCT number: NCT02621489
• Study type: Interventional
• Source: Karolinska Institutet
• Status: Completed
• Phase: Phase 4
• Start date: December 2015
• Completion date: October 2022