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NCT04530747 · ClinicalTrials.gov registry record · Phase 1
Metabolic Effects of Metformin Therapy in Obstructive Sleep Apnea
A Phase 1 study, sponsored by Pennington Biomedical Research Center.
- Terminated
- Registry status
- Phase 1
- Development phase
- 16
- Enrollment target
NCT04530747: Clinical Trial Phase 1 study, sponsored by Pennington Biomedical Research Center.
NCT04530747 is a Phase 1 study that was terminated before completion, run by Pennington Biomedical Research Center. The registered enrollment target is 16 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (73% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04530747, a Phase 1 study, was terminated before completion, sponsored by Pennington Biomedical Research Center.
- TERMINATED
- Registry status
- Phase 1
- Development phase
- 16 participants
- Enrollment target
Study Summary
The purpose of the study is to see if metformin improves metabolism in patients with obstructive sleep apnea (OSA) using positive airway pressure (PAP) therapy. Metformin is approved by the Food and Drug Administration (FDA) for the treatment and prevention of diabetes. It is not approved for use in patients with OSA.
Primary Outcome
Comparison of change in Matsuda Index as determined by 2-h oral glucose tolerance test (OGTT). During OGTT, response to oral 75g glucose intake is determined by measuring insulin and glucose in timed samples obtained at -5, 10, 20, 30, 60, 90 and 120 min. Matsuda index is a commonly used composite index to estimate whole-body insulin sensitivity. Matsuda index is calculated as (10,000/ square root of \[fasting glucose X fasting insulin\] X \[mean OGTT glucose X mean OGTT insulin\]). Increase in
Interventions
- DRUG Metformin + PAP
- DRUG Placebo oral capsule + PAP
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 16 participants |
| Start Date | 2021-01-28 |
| Est. Completion | 2021-11-30 |
| Phase | Phase 1 |
Why NCT04530747 stopped before completion
NCT04530747 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 16 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (73% lower).
The record links to 0 conditions, and to 2 interventions - of which Metformin + PAP is the first listed.
NCT04530747 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT04530747 about?
NCT04530747 is a clinical study titled "Metabolic Effects of Metformin Therapy in Obstructive Sleep Apnea". The purpose of the study is to see if metformin improves metabolism in patients with obstructive sleep apnea (OSA) using positive airway pressure (PAP) therapy. Metformin is approved by the Food and Drug Administration (FDA) for the treatment and prevention of diabetes. It is not approved for use in...
What is the current status of trial NCT04530747?
This trial is currently terminated. It is a Phase 1 study. The enrollment target is 16 participants. The study started on 2021-01-28. Estimated completion is 2021-11-30.
What interventions are being tested in trial NCT04530747?
The interventions under investigation include: Metformin + PAP (DRUG), Placebo oral capsule + PAP (DRUG).
Who is sponsoring clinical trial NCT04530747?
This trial is sponsored by Pennington Biomedical Research Center, which has 258 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT04530747's enrollment target sits among peer trials
16 1786th of 2000 higher than 203 of 2,000 other Phase 1 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 1 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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