NCT02621489

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

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
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 38 (actual)
• Sponsor: Karolinska Institutet · Academic / Other
• Sex: All
• Age: 18 Years – 80 Years
• Healthy volunteers: Not accepted

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.

Detailed 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

Conditions

• Atherosclerosis
• Diabetes
• Restenosis

Interventions

Type	Name	Description
DRUG	Bydureon	2 mg Once Weekly
DRUG	Humulin kwickpen	Humulin kwickpen 10U QD at bedtime
DRUG	Metformin	Metformin 1g BID

Timeline

• Start date: 2015-12-01
• Primary completion: 2022-08-01
• Completion: 2022-10-01
• First posted: 2015-12-03
• Last updated: 2023-04-20

Locations

1 site across 1 country: Sweden