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Phase 2Completed

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

A Phase 2, Randomized, Double-Blind, Placebo-Controlled, Multicenter Study of the Effects of PN2034 in Type 2 Diabetes Patients on Concomitant Rosiglitazone and Metformin (or Avandamet) Therapy

Sponsor
Wellstat Therapeutics (Industry)
Enrollment
90 planned
Conditions
Type 2 Diabetes Mellitus
Interventions
rosiglitazone; metformin; PN2034
Ages
adults, older adults
Registry
NCT00110851

Full record on ClinicalTrials.gov

From the registry

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).

Primary outcomes

  • Safety
  • Effect on HbA1c levels

History

  1. Last registry update

  2. Study completion

  3. Registered

  4. Started