NCT02162550

Effect of Bydureon on Carotid Atherosclerosis Progression in Type 2 Diabetes Mellitus

Effect of Bydureon on Carotid Atherosclerosis Progression in T2DM

• Status: Unknown
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 148 (estimated)
• Sponsor: Phoenix VA Health Care System · Federal
• Sex: All
• Age: 21 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

Investigators will be determining whether a once weekly injectable medication Bydureon versus placebo is able to reduce the development of atherosclerosis. Investigators are testing the overall hypothesis that 18 months of Bydureon treatment will improve cardiovascular risk factors, endothelial function and retard carotid atherosclerosis plaque progression in type 2 diabetes mellitus (T2DM). Investigators anticipate these studies will provide novel information about the temporal relationship between Bydureon induced changes in risk factors, endothelial function and atherosclerosis progression.

Detailed description

148 typical T2DM patients (ages 21-75) will participate in a rolling recruitment over approximately 2.25 years and be randomly allocated for 18 months to Bydureon (2 mg/week) or matching placebo subcutaneous injections 1x/week in a 2:1 ratio. Participants are expected to have a wide range of cardiovascular (CVD) risk and will therefore allow us to explore the importance of disease extent at baseline as a predictor of response. Blocked randomization will be used to ensure equal distribution of gender and CVD history. Carotid plaque MRI assessments will be performed at baseline, 9 and 18 months.

Conditions

• Type 2 Diabetes

Interventions

Type	Name	Description
DRUG	Bydureon	once weekly injection
DRUG	placebo	once weekly injection

Timeline

• Start date: 2014-06-01
• Primary completion: 2019-04-01
• Completion: 2019-09-01
• First posted: 2014-06-12
• Last updated: 2018-06-14

Locations

1 site across 1 country: United States