drugset / Trial / NCT00300287

A 56-Week Extension to a Clinical Study to Assess the Efficacy and Safety of Vildagliptin Compared to Placebo in Drug Naive Patients With Type 2 Diabetes and Mild Hyperglycemia

NCT00300287

Phase 3 Completed 150 enrolled Novartis
RandomizedParallel-groupDouble-blindTreatment

Summary

This study is not being conducted in the United States. Key long-term clinical studies have shown that people with type 2 diabetes should try to achieve overall blood glucose levels as close to normal as possible. The purpose of this study is to gather data on the long-term safety and effectiveness of vildagliptin, an unapproved drug, compared to placebo in lowering overall blood glucose levels in people with type 2 diabetes who have not been previously treated with drug therapy to lower their blood sugar and whose blood glucose levels are close to normal.

Timeline

Start
2006-02-20
Primary completion
2007-06-26
Completion
2007-06-26

Drugs

EvaluationDrugModalityDoseRoute
Subject Vildagliptin Other / unclassified 50 mg