NCT07685886Not yet recruitingPhase 4
MIRACLE-T2D Montelukast Intervention for Renal, Cardiovascular and Eye Health in Type 2 Diabetes
Source: ClinicalTrials.gov · Last updated 6 Jul 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Not yet recruiting
- Phase (registry)
- Phase 4
- Study type
- Interventional
- Enrollment
- 110 (estimated)
- First submitted
- 29 Jun 2026
- Start date
- 1 Sept 2026
- Primary completion date
- 30 Jun 2031
- Lead sponsor
- University of Colorado, Denver
- Diseases
- Type 2 diabetes
- NCT number
- NCT07685886
What you commit to
- Study type: Interventional · Phase 4
- Planned participants: 110
- From 1 Sept 2026 to the primary completion date, 30 Jun 2031
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Use of inhaled or systemic corticosteroids or long-acting beta agonists
Other illness
- Type 1 diabetes
- Uncontrolled hypertension
- Allergy to aspirin
- History of major psychiatric disorder
Lab values
- Hemoglobin A1C \>10%
Other
- Pregnancy or planning to become pregnant or currently breastfeeding
- Proliferative retinopathy requiring current treatment
Who the study is looking for
- Diabetes type 2
- Urine albumin to creatinine ratio 30-5000 mg/g
- CKD stage 2-3 (eGFR 30-89 ml/min/1.73m2)
- Blood pressure \< 140/90 mmHg prior to randomization
- BMI \< or = to 40 kg/m2
- Use of ACEi or ARB with stable dose for 4 weeks
- if on SGLT2i or GLP-1RA, stable dose for 3 months prior to baseline
- Able to provide consent
Age in the registry: 18 years to 80 years · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| University of Colorado Denver Coordinator of this site? Confirm its status | Aurora | United States | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.