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

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Diabetes; Kidney Disease; Vascular Disease; Retinopathy
• Intervention / Treatment: Drug: Montelukast; Drug: Placebo

• Study Type: Interventional
• Enrollment (Estimated): 110
• Phase: Phase 4

Contacts and Locations

• Study Contact: Name: Jessica Kendrick, MD MPH; Phone Number: 303-724-4837; Email: jessica.kendrick@cuanschutz.edu

Study Locations

• United States
  • Colorado
    • Aurora, Colorado, United States, 80045
      • University of Colorado Denver
      • Contact: Jessica Kendrick; Phone Number: 303-724-4837; Email: jessica.kendrick@cuanschutz.edu
      • Contact: Email: jessica.kendrick@cuanschutz.edu

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Montelukast; 10 mg capsule by mouth daily	Drug: Montelukast; 10 my by mouth daily
Placebo Comparator: Placebo; One matching capsule by mouth daily	Drug: Placebo; One capsule by mouth daily

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change from baseline in urine albumin excretion at 12 months	24-hour urine albumin	From enrollment to the end of treatment at 12 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change from baseline in creatinine clearance at 12 months		From time of enrollment until end of treatment at 12 months
Change from baseline in vascular endothelial function at 12 months	Measured by brachial artery flow mediated dilation	From enrollment to the end of treatment at 12 months
Change from baseline in arterial stiffness at 12 months	Measured by aortic pulse wave velocity	From enrollment until end of treatment at 12 months
Change from baseline in diabetic retinopathy at 12 months	Measured by OCTA	From enrollment until to the end of treatment at 12 months

Collaborators and Investigators

• Sponsor: University of Colorado, Denver
• Investigators: Principal Investigator: Jessica Kendrick, MD MPH, University of Colorado, Denver

Study record dates

Study Major Dates

• Study Start (Estimated): September 1, 2026
• Primary Completion (Estimated): June 30, 2031
• Study Completion (Estimated): August 31, 2031

Study Registration Dates

• First Submitted: June 29, 2026
• First Submitted That Met QC Criteria: June 29, 2026
• First Posted (Actual): July 6, 2026

Study Record Updates

• Last Update Posted (Actual): July 6, 2026
• Last Update Submitted That Met QC Criteria: June 29, 2026
• Last Verified: June 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Urogenital Diseases; Endocrine System Diseases; Cardiovascular Diseases; Male Urogenital Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Metabolic Diseases; Glucose Metabolism Disorders; Eye Diseases; Nutritional and Metabolic Diseases; Retinal Diseases; Diabetes Mellitus; Vascular Diseases; Kidney Diseases; montelukast
• Other Study ID Numbers: 26-1415

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: At the conclusion of the study, data, which has been stripped of all personal identification information and coded with a number, will be made available to qualified individuals within the scientific community who apply for data use. The results and outcomes of this study will be made generally available by publication and journal articles submitted to PubMed Central in compliance with NIH access guidelines.
• IPD Sharing Time Frame: At the conclusion of the study, data, which has been stripped of all personal identification information and coded with a number, will be made available to qualified individuals within the scientific community who apply for data use. The results and outcomes of this study will be made generally available by publication and journal articles submitted to PubMed Central in compliance with NIH access guidelines.
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP; ICF; ANALYTIC_CODE; CSR

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: Yes