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NCT02496780 · ClinicalTrials.gov registry record · Phase 2
The Impact of Insulin Therapy on Protein Turnover in Pre-Diabetic Cystic Fibrosis Patients
A Phase 2 study, sponsored by University of Minnesota.
- Terminated
- Registry status
- Phase 2
- Development phase
- 65
- Enrollment target
NCT02496780: Clinical Trial Phase 2 study, sponsored by University of Minnesota.
NCT02496780 is a Phase 2 study that was terminated before completion, run by University of Minnesota. The registered enrollment target is 65 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (51% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02496780, a Phase 2 study, was terminated before completion, sponsored by University of Minnesota.
- TERMINATED
- Registry status
- Phase 2
- Development phase
- 65 participants
- Enrollment target
Study Summary
Insulin replacement therapy may be effective in breaking the cycle of protein catabolism, undernutrition and overall clinical deterioration in pre-diabetic, insulin insufficient CF youth because of its potent anabolic effect. A significant number of CF patients might benefit from this therapeutic approach with a substantial impact on morbidity and mortality.
Primary Outcome
Primary endpoint. Determined from a stable isotope-labelled test meal. In the primary analysis, patients on both forms of insulin were first combined and compared to CF patients on placebo. In a second analysis, the two insulin types were separately compared to eachother and to placebo. Change in rate of endogenous protein breakdown (Ra-end) change from baseline (pre-treatment) and after 4 wks of study drug
Interventions
- DRUG placebo
- DRUG novolog insulin
- DRUG levemir insulin
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 65 participants |
| Start Date | 2015-08 |
| Est. Completion | 2022-07 |
| Phase | Phase 2 |
Why NCT02496780 stopped before completion
NCT02496780 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 65 participants, a relatively small participant target, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (51% lower).
The record links to 0 conditions, and to 3 interventions - of which placebo is the first listed.
NCT02496780 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT02496780 about?
NCT02496780 is a clinical study titled "The Impact of Insulin Therapy on Protein Turnover in Pre-Diabetic Cystic Fibrosis Patients". Insulin replacement therapy may be effective in breaking the cycle of protein catabolism, undernutrition and overall clinical deterioration in pre-diabetic, insulin insufficient CF youth because of its potent anabolic effect. A significant number of CF patients might benefit from this therapeutic ap...
What is the current status of trial NCT02496780?
This trial is currently terminated. It is a Phase 2 study. The enrollment target is 65 participants. The study started on 2015-08. Estimated completion is 2022-07.
What interventions are being tested in trial NCT02496780?
The interventions under investigation include: placebo (DRUG), novolog insulin (DRUG), levemir insulin (DRUG).
Who is sponsoring clinical trial NCT02496780?
This trial is sponsored by University of Minnesota, which has 966 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT02496780's enrollment target sits among peer trials
65 987th of 2000 higher than 1,005 of 2,000 other Phase 2 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 2 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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