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

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.

Timeline

Start

2014-06

Primary completion

2019-04

Completion

2019-09

Outcome

Missed primary endpoint

paper Mean (SD) change in plaque volume in the exenatide group (0.3% [2%]) was not different from that in the placebo group (-2.2% [8%]) (P = 0.4). PMID 33495294 ↗

paper Exenatide once weekly for up to 18 months improved fasting and postprandial glycemic control but did not modify change in carotid plaque volume or composition. PMID 33495294 ↗

Publications

• Koska J, Migrino RQ, Chan KC, Cooper-Cox K, Reaven PD. The Effect of Exenatide Once Weekly on Carotid Atherosclerosis in Individuals With Type 2 Diabetes: An 18-Month Randomized Placebo-Controlled Study. Diabetes Care. 2021 Jun;44(6):1385-1392. doi: 10.2337/dc20-2014. Epub 2021 Jan 25.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Exenatide	Peptide	2 mg	Subcutaneous

Indications