Effect of Vildagliptin vs. Glibenclamide on Circulating Endothelial Progenitor Cell Number Type 2 Diabetes

Phase 3 Completed 64 enrolled Azienda Ospedaliero-Universitaria di Parma

RandomizedParallel-groupOpen-labelTreatment

Summary

The purpose of this study is to evaluate the effect of Dipeptidyl peptidase (DPP) -IV inhibitor Vildagliptin vs. Glibenclamide on circulating endothelial progenitor cells (EPCs) number in type 2 diabetes patients in metformin failure. Subjects will be followed for 12 months after randomization.

Timeline

Start: 2010-10
Primary completion: 2014-12
Completion: 2015-01

Outcome

Met primary endpoint

registry analysis (superiority test); Vildagliptin & Metformin vs Glibenclamide & Metformin; p <0.05; Slope 0.362 (95% CI 0.028 to 0.695); ANOVA NCT01822548 ↗

paper At 12 months, V significantly increased EPC number (p < 0.05) and significantly reduced PMID 28231835 ↗

Publications

Dei Cas A, Spigoni V, Cito M, Aldigeri R, Ridolfi V, Marchesi E, Marina M, Derlindati E, Aloe R, Bonadonna RC, Zavaroni I. Vildagliptin, but not glibenclamide, increases circulating endothelial progenitor cell number: a 12-month randomized controlled trial in patients with type 2 diabetes. Cardiovasc Diabetol. 2017 Feb 23;16(1):27. doi: 10.1186/s12933-017-0503-0.

Drugs

Evaluation	Drug	Modality	Dose	Route
Comparator	Glyburide	Small molecule	10 mg	Oral
Subject	Vildagliptin	Other / unclassified	100 mg	Oral
Background	Metformin	Small molecule	2500 mg	Oral