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NCT01969084 · ClinicalTrials.gov registry record · Phase 4
The Effect of Linagliptin on Mitochondrial and Endothelial Function
A Phase 4 study, sponsored by Beth Israel Deaconess Medical Center.
- Completed
- Registry status
- Phase 4
- Development phase
- 45
- Enrollment target
NCT01969084: Completed Phase 4 study, sponsored by Beth Israel Deaconess Medical Center.
NCT01969084 is a Phase 4 study that has completed, run by Beth Israel Deaconess Medical Center. The registered enrollment target is 45 participants, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (91% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01969084, a Phase 4 study, has completed, sponsored by Beth Israel Deaconess Medical Center.
- COMPLETED
- Registry status
- Phase 4
- Development phase
- 45 participants
- Enrollment target
Study Summary
Investigators propose to examine the effect of 12 weeks of Linagliptin, a diabetes drug, treatment on inflammation as well as vascular and mitochondrial function in diabetic patients. Investigators hypothesize that Linagliptin will reduce the proinflammatory state, improve endothelial function, increase the blood flow at the muscle microcirculation level and improve mitochondrial function. In this study, investigators will perform tests that evaluate the function of small and large blood vessels by employing ultrasound and laser doppler techniques. In addition MRI scans that evaluate the mitochondrial function of the lower extremity muscles at rest and during exercise will also be employed. Forty subjects with Type 2 diabetes will be studied for twelve weeks and half of them will be randomly assigned to receive linagliptin while the other half will receive placebo. All tests will be performed at the beginning and the end of the study.
Primary Outcome
Change in the time to phosphocreatine recovery between the baseline visit and post-treatment visit following the graded exercise test.
Interventions
- DRUG Placebo
- DRUG Linagliptin
- OTHER Microcirculation testing
- OTHER Macrocirculation testing
- OTHER MRI Scans
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 45 participants |
| Start Date | 2013-10 |
| Est. Completion | 2016-07 |
| Phase | Phase 4 |
What the finished NCT01969084 record still lists
NCT01969084 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 45 participants, a relatively small participant target, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (91% lower).
The record links to 0 conditions, and to 5 interventions - of which Placebo is the first listed.
NCT01969084 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01969084 about?
NCT01969084 is a clinical study titled "The Effect of Linagliptin on Mitochondrial and Endothelial Function". Investigators propose to examine the effect of 12 weeks of Linagliptin, a diabetes drug, treatment on inflammation as well as vascular and mitochondrial function in diabetic patients. Investigators hypothesize that Linagliptin will reduce the proinflammatory state, improve endothelial function, incr...
What is the current status of trial NCT01969084?
This trial is currently completed. It is a Phase 4 study. The enrollment target is 45 participants. The study started on 2013-10. Estimated completion is 2016-07.
What interventions are being tested in trial NCT01969084?
The interventions under investigation include: Placebo (DRUG), Linagliptin (DRUG), Microcirculation testing (OTHER), Macrocirculation testing (OTHER), MRI Scans (OTHER).
Who is sponsoring clinical trial NCT01969084?
This trial is sponsored by Beth Israel Deaconess Medical Center, which has 488 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01969084's enrollment target sits among peer trials
45 1354th of 2000 higher than 638 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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