drugset / Trial / NCT00616811

Safety and Tolerability of Vildagliptin Versus Sitagliptin in Patients With Type 2 Diabetes and Severe Renal Insufficiency

NCT00616811

Phase 3 Completed 148 enrolled Novartis
RandomizedParallel-groupTriple-blindTreatment

Summary

This clinical trial is designed to provide additional information on the safety and tolerability of vildagliptin (50 mg once daily (qd)) and sitagliptin (25 mg qd) when used in patients with type 2 diabetes mellitus(T2DM) and severe renal insufficiency (Glomerular filtration rate (GFR) \< 30 mL/min) for a period of 24 weeks.

Timeline

Start
2008-01
Primary completion
2010-10
Completion
2010-10

Drugs

EvaluationDrugModalityDoseRoute
Comparator Sitagliptin Small molecule 25 mg
Subject Vildagliptin Other / unclassified 50 mg