Efficacy and Safety of Vildagliptin Versus Placebo in Patients With Type 2 Diabetes

Phase 3 Completed 28 enrolled Novartis

RandomizedCrossoverDouble-blindTreatment

Summary

This mechanistic study is designed to investigate the effect of vildagliptin on the sensitivity of the a-cell to glucose under hypoglycemic conditions in patients with type 2 diabetes (T2DM).

Timeline

Start: 2006-09
Primary completion: 2007-09
Completion: 2007-09

Outcome

Met primary endpoint

paper the between-treatment difference was 12.8 +/- 7.0 ng/liter (P = 0.039), representing a 38% increase with vildagliptin. PMID 19174497 ↗

paper the between-treatment difference was -349 +/- 158 ng/liter x min (P = 0.019), representing a 41% decrease with vildagliptin. PMID 19174497 ↗

Publications

Ahren B, Schweizer A, Dejager S, Dunning BE, Nilsson PM, Persson M, Foley JE. Vildagliptin enhances islet responsiveness to both hyper- and hypoglycemia in patients with type 2 diabetes. J Clin Endocrinol Metab. 2009 Apr;94(4):1236-43. doi: 10.1210/jc.2008-2152. Epub 2009 Jan 27.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Vildagliptin	Other / unclassified	100 mg	—