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NCT02024477 · ClinicalTrials.gov registry record · Phase 4
Effect of Saxagliptin on EPCs as a Cellular Biomarker for Evaluating Endothelial Dysfunction in Early T2DM Patients
A Phase 4 study of Type 2 Diabetes, sponsored by George Washington University.
- Completed
- Registry status
- Phase 4
- Development phase
- 42
- Enrollment target
- 1
- Study location
NCT02024477: Completed Phase 4 study of Type 2 Diabetes, sponsored by George Washington University.
NCT02024477 is a Phase 4 study of Type 2 Diabetes that has completed, run by George Washington University. The registered enrollment target is 42 participants, below the 3,924-participant average among 327 other Type 2 Diabetes trials with a reported enrollment target (99% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02024477, a Phase 4 study of Type 2 Diabetes, has completed, sponsored by George Washington University.
- COMPLETED
- Registry status
- Phase 4
- Development phase
- 42 participants
- Enrollment target
- 1
- Study location
Study Summary
Type 2 diabetes is a national epidemic. Diabetes has undesirable effects on blood vessels which may contribute to heart disease. Endothelial Progenitor Cells(EPCs) are found in the blood . Research has shown that improving the survival of these special blood cells may decrease the harmful effects of diabetes on blood vessels and reduce or reverse heart disease. Saxagliptin is an FDA(Food and Drug Administration) approved prescription medicine used along with diet and exercise to lower blood sugar in people with Type 2 diabetes. It is in a class of diabetes medication called DPP-4 inhibitors. DPP-4 inhibitors have been shown to increase EPCs in patients with Type 2 diabetes. Hypothesis: We believe poor viability and function of EPCs in early diabetes ultimately affects the repair and regeneration of the endothelium and that prompt intervention using saxagliptin with another oral hypoglycemic agent, Metformin, may reduce or reverse cardiovascular risk by improving EPC survival and function above and beyond adequate glucose metabolism control.
Primary Outcome
We will use patient's peripheral blood derived CD34+ cells looking at number of CD34+ Endothelial Progenitor Cell as % of the total Mononuclear cell population. Post saxagliptin will be compared to pre saxagliptin measurement
Conditions Studied
Interventions
- DRUG Placebo
- DRUG Saxagliptin
Study Locations (1)
District of Columbia
- Medical Faculty Associates Inc - Washington D.C.
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 42 participants |
| Start Date | 2013-11 |
| Est. Completion | 2017-12 |
| Phase | Phase 4 |
What the finished NCT02024477 record still lists
NCT02024477 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 42 participants, a relatively small participant target, below the 3,924-participant average among 327 other Type 2 Diabetes trials with a reported enrollment target (99% lower).
The record links to 1 condition, with Type 2 Diabetes appearing as the primary indexed condition, and to 2 interventions - of which Placebo is the first listed.
NCT02024477 reports a single indexed study location in District of Columbia.
Frequently Asked Questions
What is clinical trial NCT02024477 about?
NCT02024477 is a clinical study titled "Effect of Saxagliptin on EPCs as a Cellular Biomarker for Evaluating Endothelial Dysfunction in Early T2DM Patients". Type 2 diabetes is a national epidemic. Diabetes has undesirable effects on blood vessels which may contribute to heart disease. Endothelial Progenitor Cells(EPCs) are found in the blood . Research has shown that improving the survival of these special blood cells may decrease the harmful effects of...
What is the current status of trial NCT02024477?
This trial is currently completed. It is a Phase 4 study. The enrollment target is 42 participants. The study started on 2013-11. Estimated completion is 2017-12.
What conditions does trial NCT02024477 study?
This clinical trial studies the following conditions: Type 2 Diabetes.
What interventions are being tested in trial NCT02024477?
The interventions under investigation include: Placebo (DRUG), Saxagliptin (DRUG).
Who is sponsoring clinical trial NCT02024477?
This trial is sponsored by George Washington University, which has 133 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT02024477 being conducted?
This trial has 1 study location across District of Columbia. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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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 NCT02024477's enrollment target sits among peer trials
42 225th of 327 higher than 99 of 327 other Type 2 Diabetes trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Type 2 Diabetes 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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