Efficacy and Safety of Vildagliptin in Combination With Pioglitazone in Patients With Type 2 Diabetes

Phase 3 Completed 362 enrolled Novartis Pharmaceuticals

RandomizedParallel-groupQuadruple-blindTreatment

Summary

Many people with type 2 diabetes cannot maintain target blood glucose levels when taking a single oral drug. The purpose of this study is to assess the safety and effectiveness of vildagliptin, an unapproved drug, in lowering overall blood glucose levels when added to pioglitazone in people with type 2 diabetes not at target blood glucose levels on either pioglitazone or rosiglitazone alone.

Timeline

Start: 2004-05
Primary completion: 2008-01
Completion: 2008-01

Outcome

Met primary endpoint

paper The adjusted mean change (AM Delta) in haemoglobin A(1c) from baseline to endpoint was -0.8 +/- 0.1% (p = 0.001 vs. placebo) PMID 17300592 ↗

Publications

Garber AJ, Schweizer A, Baron MA, Rochotte E, Dejager S. Vildagliptin in combination with pioglitazone improves glycaemic control in patients with type 2 diabetes failing thiazolidinedione monotherapy: a randomized, placebo-controlled study. Diabetes Obes Metab. 2007 Mar;9(2):166-74. doi: 10.1111/j.1463-1326.2006.00684.x.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Vildagliptin	Other / unclassified	50 mg	—
Background	Pioglitazone	Small molecule	45 mg	—