drugset / Trial / NCT00099944

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

NCT00099944

Phase 3 Completed 515 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 two doses of vildagliptin, an unapproved drug, in lowering overall blood glucose levels when added to glimepiride in people with type 2 diabetes not at target blood glucose levels on a sulfonylurea alone.

Timeline

Start
2004-05
Primary completion
2005-10
Completion
2005-10

Drugs

EvaluationDrugModalityDoseRoute
Subject Vildagliptin Other / unclassified 50 mg
Subject Vildagliptin Other / unclassified 100 mg
Background Glimepiride Small molecule 4 mg