Trials / Completed
CompletedNCT00110851
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
- Status
- Completed
- Phase
- Phase 2
- Study type
- Interventional
- Enrollment
- 90 (estimated)
- Sponsor
- Wellstat Therapeutics · Industry
- Sex
- All
- Age
- 21 Years – 72 Years
- Healthy volunteers
- Not accepted
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).
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | rosiglitazone | |
| DRUG | metformin | |
| DRUG | PN2034 |
Timeline
- Start date
- 2005-04-01
- Completion
- 2007-08-01
- First posted
- 2005-05-16
- Last updated
- 2007-08-23
Locations
20 sites across 1 country: United States
Source: ClinicalTrials.gov record NCT00110851. Inclusion in this directory is not an endorsement.