drugset / Trial / NCT00110851

Safety and Efficacy Study of PN2034 in Type 2 Diabetes Patients on Concomitant Rosiglitazone and Metformin (or Avandamet)

NCT00110851

Phase 2 Completed 90 enrolled Wellstat Therapeutics
RandomizedParallel-groupDouble-blindTreatment

Summary

This study is designed to evaluate the safety and efficacy of PN2034 administered to type 2 diabetics on concomitant rosiglitazone and metformin (or Avandamet) therapy as measured by change in glycosylated hemoglobin (HbA1c) levels from baseline to Week 12. Also the study will evaluate the effect of PN2034 on glucose control as measured by fasting plasma glucose (FPG) and on fasting lipid levels: triglycerides, total cholesterol, high-density lipoproteins (HDL), low-density lipoproteins (LDL), and very low-density lipoproteins (VLDL).

Timeline

Start
2005-04
Primary completion
Completion
2007-08

Drugs

EvaluationDrugModalityDoseRoute
Subject PN2034 Unknown
Background Metformin Small molecule
Background Rosiglitazone Small molecule