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Safety and Efficacy Study of PN2034 in Type 2 Diabetes Patients on Concomitant Rosiglitazone and Metformin (or Avandamet)
NCT00110851 · View on ClinicalTrials.gov ↗
Study 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 Studied
Interventions
- DRUG metformin
- DRUG rosiglitazone
- DRUG PN2034
Study Locations (20)
Florida
- University Clinical Research-DeLand — DeLand
- Center for Diabetes and Endocrine Care — Hollywood
- Genesis Research International — Longwood
- Baptist Diabetes Associates — Miami
- Andres Patron, DO PA — Pembroke Pines
- CLIRECO, Inc. — Tamarac
- Endocrine Clinical Research — Winter Park
North Carolina
- Medical Research Associates of Charlotte — Charlotte
- Neem Research Group of Charlotte — Charlotte
- Unifour Medical Research Associates — Hickory
- Neem Research Group of Raleigh — Raleigh
- Piedmont Medical Research Associates — Winston-Salem
South Carolina
- Neem Research Group — Columbia
- Palmetto Medical Research Associates — Mt. Pleasant
Connecticut
- Phoenix Internal Medicine Associates — Waterbury
Kansas
- PRN of Kansas — Wichita
Oklahoma
- COR Clinical Research, LLC — Oklahoma City
Oregon
- Clinical Research Institute of Southern Oregon, PC — Medford
Pennsylvania
- Camp Hill Clinical Research Center — Camp Hill
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 90 participants |
| Start Date | 2005-04 |
| Est. Completion | 2007-08 |
| Phase | Phase 2 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00110851
The ClinicalTrials.gov registry entry for NCT00110851 describes a study currently listed as completed. It is categorized as Phase 2, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 90 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Wellstat Therapeutics, which has 2 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.
The record links to 1 condition, with Type 2 Diabetes Mellitus appearing as the primary indexed condition, and to 3 interventions — of which metformin is the first listed. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.
Geographic footprint matters for practical reasons: NCT00110851 reports 20 study locations spanning 9 distinct geographic areas — top geographies include Florida, North Carolina, South Carolina. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.
Frequently Asked Questions
What is clinical trial NCT00110851 about?
NCT00110851 is a clinical study titled "Safety and Efficacy Study of PN2034 in Type 2 Diabetes Patients on Concomitant Rosiglitazone and Metformin (or Avandamet)". 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...
What is the current status of trial NCT00110851?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 90 participants. The study started on 2005-04. Estimated completion is 2007-08.
What conditions does trial NCT00110851 study?
This clinical trial studies the following conditions: Type 2 Diabetes Mellitus. These conditions were identified from the trial registry and reflect the primary focus areas of the research.
What interventions are being tested in trial NCT00110851?
The interventions under investigation include: metformin (DRUG), rosiglitazone (DRUG), PN2034 (DRUG). Each intervention is being evaluated for safety and efficacy as part of this clinical study.
Who is sponsoring clinical trial NCT00110851?
This trial is sponsored by Wellstat Therapeutics, which has 2 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.
Where is trial NCT00110851 being conducted?
This trial has 20 study locations across Connecticut, Florida, Kansas, North Carolina, Oklahoma. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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