drugset / Trial / NCT00770081

Safety and Tolerability of Vildagliptin Versus Sitagliptin in Patients With Type 2 Diabetes and Severe Renal Insufficiency (28-week Extension Study)

NCT00770081

Phase 3 Completed 75 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 52 weeks.

Timeline

Start
2008-09
Primary completion
2011-04
Completion
2011-04

Drugs

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