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NCT Number: NCT07685886

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, 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.

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Key information

Conditions

Diabetes Cardiovascular Diseases Diabetes Mellitus Endocrine System Diseases Eye Diseases Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Glucose Metabolism Disorders Kidney Disease Kidney Diseases Male Urogenital Diseases Metabolic Diseases Nutritional and Metabolic Diseases Retinal Diseases Retinopathy Urogenital Diseases Urologic Diseases Vascular Disease Vascular Diseases

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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

Exclusion criteria

  • 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

Treatment and study plan

Montelukast

Drug

10 my by mouth daily

Placebo

Drug

One capsule by mouth daily

Primary outcomes

  1. Change from baseline in urine albumin excretion at 12 months

    Time frame: From enrollment to the end of treatment at 12 months

    24-hour urine albumin

Secondary outcomes

  1. Change from baseline in creatinine clearance at 12 months

    Time frame: From time of enrollment until end of treatment at 12 months

  2. Change from baseline in vascular endothelial function at 12 months

    Time frame: From enrollment to the end of treatment at 12 months

    Measured by brachial artery flow mediated dilation

  3. Change from baseline in arterial stiffness at 12 months

    Time frame: From enrollment until end of treatment at 12 months

    Measured by aortic pulse wave velocity

  4. Change from baseline in diabetic retinopathy at 12 months

    Time frame: From enrollment until to the end of treatment at 12 months

    Measured by OCTA

Study contacts

Contact information is provided by the study sponsor or research team.

Jessica Kendrick, MD MPH

CONTACT

[email protected]

303-724-4837

Sponsors and collaborators

Lead sponsor

University of Colorado, Denver

Other

Registry information

Acronym: MIRACLE-T2D

Important dates

Study start
2026
Primary completion
2031
Study completion
2031
First posted
Jul 6, 2026
Registry last updated
Jul 6, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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