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NCT02467478 · ClinicalTrials.gov registry record · Phase 4
Linagliptin's Effect on CD34+ Stem Cells
A Phase 4 study, sponsored by George Washington University.
- Completed
- Registry status
- Phase 4
- Development phase
- 31
- Enrollment target
NCT02467478: Completed Phase 4 study, sponsored by George Washington University.
NCT02467478 is a Phase 4 study that has completed, run by George Washington University. The registered enrollment target is 31 participants, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (94% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02467478, a Phase 4 study, has completed, sponsored by George Washington University.
- COMPLETED
- Registry status
- Phase 4
- Development phase
- 31 participants
- Enrollment target
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. Linagliptin is an Food and Drug Administration (FDA) approved prescription medicine used along with insulin or with oral medications to lower blood sugar in people with Type 2 diabetes. It is in a class of diabetes medication called Dipeptidyl peptidase-4 (DPP-4) inhibitors. DPP-4 inhibitors have been shown to increase EPCs in patients with Type 2 diabetes. Hypothesis: Both type 2 diabetes and Chronic Kidney Disease (CKD) are associated with poor stem cell number and function. Poor viability and function of EPCs in CKD and diabetes The investigators hypothesize that use of Linagliptin (along with Insulin) may help reduce cardiovascular risk by improving EPC survival and function above and beyond adequate glucose metabolism control
Primary Outcome
The investigators will use participants' peripheral blood derived CD34+ cells looking at number, function, and gene expression. Post Linagliptin will be compared to pre Linagliptin measurements. Here we report fold changes in protein populations as determined by ELISA.
Interventions
- DRUG Placebo
- DRUG Linagliptin
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 31 participants |
| Start Date | 2015-04 |
| Est. Completion | 2019-12 |
| Phase | Phase 4 |
What the finished NCT02467478 record still lists
NCT02467478 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 31 participants, a relatively small participant target, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (94% lower).
The record links to 0 conditions, and to 2 interventions - of which Placebo is the first listed.
NCT02467478 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT02467478 about?
NCT02467478 is a clinical study titled "Linagliptin's Effect on CD34+ Stem Cells". 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 NCT02467478?
This trial is currently completed. It is a Phase 4 study. The enrollment target is 31 participants. The study started on 2015-04. Estimated completion is 2019-12.
What interventions are being tested in trial NCT02467478?
The interventions under investigation include: Placebo (DRUG), Linagliptin (DRUG).
Who is sponsoring clinical trial NCT02467478?
This trial is sponsored by George Washington University, which has 133 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT02467478's enrollment target sits among peer trials
31 1544th of 2000 higher than 449 of 2,000 other Phase 4 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 4 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.
Source ClinicalTrials.gov registry export · 2026-08-08
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