The Vascular Effects of Exenatide Versus Metformin in Patients With Pre-Diabetes

Phase 4 Completed 50 enrolled St. Paul Heart Clinic Amylin Pharmaceuticals, LLC. · collab Eli Lilly and Company · collab International Diabetes Center at Park Nicollet · collab

RandomizedParallel-groupOpen-labelTreatment

Summary

The purpose of this study is to compare the effects of exenatide versus metformin on vascular health with chronic (3-month) therapy and during a 2-hour period following a meal in patients with pre-diabetes. It is predicted that exenatide will improve vascular health to a greater degree compared to metformin.

Timeline

Start: 2007-10
Primary completion: 2011-07
Completion: 2011-07

Outcome

Missed primary endpoint

paper There were no differences for the change in RHI (Δ exenatide: 0.01 ± 0.68 vs. Δ metformin: -0.17 ± 0.72, P = 0.348) PMID 22681705 ↗

Publications

Kelly AS, Bergenstal RM, Gonzalez-Campoy JM, Katz H, Bank AJ. Effects of exenatide vs. metformin on endothelial function in obese patients with pre-diabetes: a randomized trial. Cardiovasc Diabetol. 2012 Jun 8;11:64. doi: 10.1186/1475-2840-11-64.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Exenatide	Peptide	10 ug	—
Comparator	Metformin	Small molecule	500 mg	—