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NCT00110851 · ClinicalTrials.gov registry record · Phase 2
Safety and Efficacy Study of PN2034 in Type 2 Diabetes Patients on Concomitant Rosiglitazone and Metformin (or Avandamet)
A Phase 2 study of Type 2 Diabetes Mellitus, sponsored by Wellstat Therapeutics.
- Completed
- Registry status
- Phase 2
- Development phase
- 90
- Enrollment target
- 20
- Study locations
NCT00110851: Completed Phase 2 study of Type 2 Diabetes Mellitus, sponsored by Wellstat Therapeutics.
NCT00110851 is a Phase 2 study of Type 2 Diabetes Mellitus that has completed, run by Wellstat Therapeutics. The registered enrollment target is 90 participants, below the 2,959-participant average among 130 other Type 2 Diabetes Mellitus trials with a reported enrollment target (97% lower). The trial reports 20 study locations across 9 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00110851, a Phase 2 study of Type 2 Diabetes Mellitus, has completed, sponsored by Wellstat Therapeutics.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 90 participants
- Enrollment target
- 20
- Study locations
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 |
What the finished NCT00110851 record still lists
NCT00110851 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 90 participants, a relatively small participant target, below the 2,959-participant average among 130 other Type 2 Diabetes Mellitus trials with a reported enrollment target (97% lower).
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.
NCT00110851 names 20 study sites across 9 states, led by Florida, North Carolina, South Carolina.
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.
What interventions are being tested in trial NCT00110851?
The interventions under investigation include: metformin (DRUG), rosiglitazone (DRUG), PN2034 (DRUG).
Who is sponsoring clinical trial NCT00110851?
This trial is sponsored by Wellstat Therapeutics, which has 5 total clinical trials registered on ClinicalTrials.gov.
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.
Learn More About Clinical Trials
Similar trials for Type 2 Diabetes Mellitus
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT00110851's enrollment target sits among peer trials
90 58th of 130 higher than 72 of 130 other Type 2 Diabetes Mellitus trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Type 2 Diabetes Mellitus trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
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