drugset / Trial / NCT00138619

Extension to a Study on the Efficacy and Safety of Vildagliptin Compared to Rosiglitazone in Drug Naive Patients With Type 2 Diabetes

NCT00138619

Phase 3 Completed 478 enrolled Novartis
RandomizedParallel-groupDouble-blindTreatment

Summary

This is an 80-week extension to a study to assess the safety and effectiveness of vildagliptin, an unapproved drug, compared to rosiglitazone in lowering overall blood glucose levels in people with type 2 diabetes who have not previously been treated with drug therapy to lower their blood sugar. The purpose of the extension study is to gather data on the long-term safety and effectiveness of vildagliptin in people with type 2 diabetes.

Timeline

Start
2004-11
Primary completion
2007-04
Completion
2007-04

Drugs

EvaluationDrugModalityDoseRoute
Subject Vildagliptin Other / unclassified 50 mg