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NCT07685886 · ClinicalTrials.gov registry record · Phase 4
MIRACLE-T2D Montelukast Intervention for Renal, Cardiovascular and Eye Health in Type 2 Diabetes
A Phase 4 study, sponsored by University of Colorado, Denver.
- Not yet
- Registry status
- Phase 4
- Development phase
- 110
- Enrollment target
NCT07685886: Clinical Trial Phase 4 study, sponsored by University of Colorado, Denver.
NCT07685886 is a Phase 4 study that has not yet begun recruiting, run by University of Colorado, Denver. The registered enrollment target is 110 participants, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (79% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT07685886, a Phase 4 study, has not yet begun recruiting, sponsored by University of Colorado, Denver.
- NOT YET RECRUITING
- Registry status
- Phase 4
- Development phase
- 110 participants
- Enrollment target
Study Summary
Diabetes mellitus type 2 is associated with significant morbidity and mortality; and identifying new treatments for diabetes complications to be used alone or in combination with other therapies is a high priority. Hyperglycemia triggers proinflammatory pathways leading to damage in the kidneys, eyes and blood vessels; thus targeting proinflammatory lipid mediators called leukotrienes may represent a promising therapy for diabetes complications. This clinical trial seeks to investigate whether montelukast, a leukotriene antagonist, improves kidney, eye and vascular function in adult participants with type 2 diabetes and kidney disease.
Primary Outcome
24-hour urine albumin
Interventions
- DRUG Placebo
- DRUG Montelukast
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 110 participants |
| Start Date | 2026-09-01 |
| Est. Completion | 2031-08-31 |
| Phase | Phase 4 |
What is known before NCT07685886 opens enrollment
NCT07685886 is an interventional study that assigns participants to a tested intervention. The registered 110 participants enrollment target is mid-sized for trials with a published cap, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (79% lower).
The record links to 0 conditions, and to 2 interventions - of which Placebo is the first listed.
NCT07685886 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT07685886 about?
NCT07685886 is a clinical study titled "MIRACLE-T2D Montelukast Intervention for Renal, Cardiovascular and Eye Health in Type 2 Diabetes". Diabetes mellitus type 2 is associated with significant morbidity and mortality; and identifying new treatments for diabetes complications to be used alone or in combination with other therapies is a high priority. Hyperglycemia triggers proinflammatory pathways leading to damage in the kidneys, eye...
What is the current status of trial NCT07685886?
This trial is currently not yet recruiting. It is a Phase 4 study. The enrollment target is 110 participants. The study started on 2026-09-01. Estimated completion is 2031-08-31.
What interventions are being tested in trial NCT07685886?
The interventions under investigation include: Placebo (DRUG), Montelukast (DRUG).
Who is sponsoring clinical trial NCT07685886?
This trial is sponsored by University of Colorado, Denver, which has 1,283 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT07685886's enrollment target sits among peer trials
110 727th of 2000 higher than 1,264 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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