drugset / Trial / NCT00237237

Vildagliptin Compared to Pioglitazone in Combination With Metformin in Patients With Type 2 Diabetes

NCT00237237 ↗

Phase 3 Completed 588 enrolled Novartis
RandomizedParallel-groupDouble-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 long-term safety and effectiveness of vildagliptin, an unapproved drug, compared to that of pioglitazone in lowering overall blood glucose levels when added to metformin in people with type 2 diabetes not at target blood glucose levels on metformin alone.

Timeline

Start
2005-10
Primary completion
2007-02
Completion
—

Outcome

Met primary endpoint

paper non-inferiority of vildagliptin to pioglitazone was established at both 0.4 and 0.3% margins for upper limit of the 95% confidence intervals. PMID 18034842 ↗

Drugs

EvaluationDrugModalityDoseRoute
Subject Vildagliptin Other / unclassified 100 mg —