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NCT01928199 · ClinicalTrials.gov registry record · Phase 4
Efficacy Study of Sitagliptin to Prevent New-onset Diabetes After Kidney Transplant
A Phase 4 study, sponsored by Washington University School of Medicine.
- Completed
- Registry status
- Phase 4
- Development phase
- 61
- Enrollment target
NCT01928199: Completed Phase 4 study, sponsored by Washington University School of Medicine.
NCT01928199 is a Phase 4 study that has completed, run by Washington University School of Medicine. The registered enrollment target is 61 participants, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (88% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01928199, a Phase 4 study, has completed, sponsored by Washington University School of Medicine.
- COMPLETED
- Registry status
- Phase 4
- Development phase
- 61 participants
- Enrollment target
Study Summary
The purpose of this study is to determine whether sitagliptin is effective in preventing the development of new-onset diabetes after kidney transplant (NODAT). Up to one-third of previously non-diabetic patients develop NODAT after a kidney transplant. Corticosteroids and calcineurin inhibitors are two commonly utilized anti-rejection medications that contribute to diabetes development through multiple mechanisms; including decreased insulin production by the pancreas. Sitagliptin is an oral medication that results in increased insulin secretion. We hypothesize that administration of sitagliptin to transplant recipients identified to be at risk for diabetes development will reduce the incidence and severity of NODAT.
Primary Outcome
Change in 2-hour OGTT-derived blood sugar will be measured at three months and again at six months. These are 3 month OGTT results
Interventions
- DRUG Placebo
- DRUG Sitagliptin
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 61 participants |
| Start Date | 2013-09 |
| Est. Completion | 2020-10 |
| Phase | Phase 4 |
What the finished NCT01928199 record still lists
NCT01928199 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 61 participants, a relatively small participant target, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (88% lower).
The record links to 0 conditions, and to 2 interventions - of which Placebo is the first listed.
NCT01928199 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01928199 about?
NCT01928199 is a clinical study titled "Efficacy Study of Sitagliptin to Prevent New-onset Diabetes After Kidney Transplant". The purpose of this study is to determine whether sitagliptin is effective in preventing the development of new-onset diabetes after kidney transplant (NODAT). Up to one-third of previously non-diabetic patients develop NODAT after a kidney transplant. Corticosteroids and calcineurin inhibitors are ...
What is the current status of trial NCT01928199?
This trial is currently completed. It is a Phase 4 study. The enrollment target is 61 participants. The study started on 2013-09. Estimated completion is 2020-10.
What interventions are being tested in trial NCT01928199?
The interventions under investigation include: Placebo (DRUG), Sitagliptin (DRUG).
Who is sponsoring clinical trial NCT01928199?
This trial is sponsored by Washington University School of Medicine, which has 1,502 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01928199's enrollment target sits among peer trials
61 1119th of 2000 higher than 876 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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