A Clinical Study to Assess the Effect of Vildagliptin on Beta Cell Function in Drug Naive Patients With Type 2 Diabetes

Phase 3 Completed 59 enrolled Novartis Pharmaceuticals

RandomizedParallel-groupDouble-blindTreatment

Summary

This study is not being conducted in the United States. The purpose of this study is to assess the effect of vildagliptin, an unapproved drug, on various measures of pancreatic islet function in people with type 2 diabetes who have not previously been treated with drug therapy to lower their blood sugar.

Timeline

Start: 2005-11
Primary completion: 2008-12
Completion: 2008-12

Outcome

Met primary endpoint

paper treatment increased the primary efficacy variable PMID 21547496 ↗

paper between-group difference p = 0.030 PMID 21547496 ↗

Publications

Foley JE, Bunck MC, Moller-Goede DL, Poelma M, Nijpels G, Eekhoff EM, Schweizer A, Heine RJ, Diamant M. Beta cell function following 1 year vildagliptin or placebo treatment and after 12 week washout in drug-naive patients with type 2 diabetes and mild hyperglycaemia: a randomised controlled trial. Diabetologia. 2011 Aug;54(8):1985-91. doi: 10.1007/s00125-011-2167-8. Epub 2011 May 6.

Drugs

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