Effects of Antidiabetic Medications on the Postprandial State in Prediabetes

Phase 4 Completed 21 enrolled The University of Texas Health Science Center, Houston The Center for Clinical and Translational Sciences (CCTS) Clinical Research Unit at The University of Texas Health Science Center at Houston · collab

RandomizedCrossoverQuadruple-blindTreatment

Summary

This project addresses cardiovascular disease risk in patients with prediabetes. Levels of lipids after eating a meal ("postprandial lipids") are strong independent predictors of cardiovascular risk. Newer anti-diabetic agents - exenatide and saxagliptin - impact lipid metabolism. These medications will be studied for their effect in reducing both postprandial lipid levels and arterial dysfunction.

Timeline

Start: 2014-04
Primary completion: 2017-03
Completion: 2017-03

Outcome

Missed primary endpoint

registry analysis (superiority test); Exenatide; p = 0.27; Non-parametric Wilcoxon paired rank sum NCT02104739 ↗

registry analysis (superiority test); Saxagliptin; p = 0.59; Non-parametric Wilcoxon paired rank sum NCT02104739 ↗

registry analysis (superiority test); Placebo; p = 0.51; Non-parametric Wilcoxon paired rank sum NCT02104739 ↗

registry analysis (superiority test); Exenatide Extended-release (ER); p = 0.31; Non-parametric Wilcoxon paired rank sum NCT02104739 ↗

Publications

Hamidi V, Riggs K, Zhu L, Bermudez Saint Andre K, Westby C, Coverdale S, Dursteler A, Wang H, Miller Iii C, Taegtmeyer H, Gutierrez AD. Acute Exenatide Therapy Attenuates Postprandial Vasodilation in Humans with Prediabetes: A Randomized Controlled Trial. Metab Syndr Relat Disord. 2020 Jun;18(5):225-233. doi: 10.1089/met.2019.0102. Epub 2020 Mar 31.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Exenatide	Peptide	10 ug	Subcutaneous
Subject	Exenatide extended-release (ER)	Unknown	2 mg	Subcutaneous
Subject	SAXAGLIPTIN ANHYDROUS	Small molecule	5 mg	Oral