Efficacy of Vildagliptin 100 MG as Compared to Placebo as Add-on to Metformin in Patients With Type 2 Diabetes

Phase 3 Completed 370 enrolled Novartis Pharmaceuticals

RandomizedParallel-groupTriple-blindTreatment

Summary

Vildagliptin is an oral anti-diabetic agent. This is a 24-week study to assess the efficacy on HbA1c of 100 mg vildagliptin once daily as compared to placebo as add-on to metformin in patients with type 2 diabetes inadequately controlled with metformin.

Timeline

Start: 2006-05
Primary completion: 2007-11
Completion: —

Outcome

Met primary endpoint

paper Change from baseline to study endpoint in adjusted mean (SE) HbA(1c) improved significantly with vildagliptin AM dosing (-0.66 [0.11] versus 0.17% [0.11] with placebo; p <0.001). PMID 19221978 ↗

Publications

Results Goodman M, Thurston H, Penman J. Efficacy and tolerability of vildagliptin in patients with type 2 diabetes inadequately controlled with metformin monotherapy. Horm Metab Res. 2009 May;41(5):368-73. doi: 10.1055/s-0028-1104604. Epub 2009 Feb 16.

Drugs

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