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

Phase 3 Completed 254 enrolled Novartis Pharmaceuticals

RandomizedParallel-groupDouble-blindTreatment

Summary

Many people with type 2 diabetes cannot maintain their target blood glucose levels on a single therapy. 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 insulin in people with type 2 diabetes who are not at target blood glucose levels on insulin alone.

Timeline

Start: 2004-05
Primary completion: 2005-06
Completion: 2005-06

Outcome

Met primary endpoint

paper HbA(1c) was -0.5 +/- 0.1% and -0.2 +/- 0.1% in patients receiving vildagliptin or placebo, respectively, with a significant between-treatment difference (p = 0.01). PMID 17387446 ↗

Publications

Fonseca V, Schweizer A, Albrecht D, Baron MA, Chang I, Dejager S. Addition of vildagliptin to insulin improves glycaemic control in type 2 diabetes. Diabetologia. 2007 Jun;50(6):1148-55. doi: 10.1007/s00125-007-0633-0. Epub 2007 Mar 27.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Vildagliptin	Other / unclassified	50 mg	—