MIRACLE-T2D Montelukast Intervention for Renal, Cardiovascular and Eye Health in Type 2 Diabetes

Starting soon · Phase 4 · Has a placebo group

Conditions studied: Diabetes, Kidney Disease, Vascular Disease, Retinopathy

In brief

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.

Key facts

Study ID

NCT07685886

Run by

University of Colorado, Denver

People needed

110

Starts

2026-09-01

Expected to finish

2031-08-31

Last updated by the study team

2026-07-06

Who can join

Age: 18 and older, up to 80. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• Type 1 diabetes
• Uncontrolled hypertension
• Hemoglobin A1C >10%
• Pregnancy or planning to become pregnant or currently breastfeeding
• Allergy to aspirin
• History of major psychiatric disorder
• Use of inhaled or systemic corticosteroids or long-acting beta agonists
• Proliferative retinopathy requiring current treatment

Where it is running

• University of Colorado Denver — Aurora, Colorado, United States

Full record on ClinicalTrials.gov

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