MIRACLE-T2D Montelukast Intervention for Renal, Cardiovascular and Eye Health in Type 2 Diabetes
MIRACLE-T2D
1 other identifier
interventional
110
1 country
1
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_4 diabetes
Started Sep 2026
Longer than P75 for phase_4 diabetes
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
June 29, 2026
CompletedFirst Posted
Study publicly available on registry
July 6, 2026
CompletedStudy Start
First participant enrolled
September 1, 2026
ExpectedPrimary Completion
Last participant's last visit for primary outcome
June 30, 2031
Study Completion
Last participant's last visit for all outcomes
August 31, 2031
July 6, 2026
June 1, 2026
4.8 years
June 29, 2026
June 29, 2026
Conditions
Outcome Measures
Primary Outcomes (1)
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 Outcomes (4)
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
From enrollment to the end of treatment at 12 months
Change from baseline in arterial stiffness at 12 months
From enrollment until end of treatment at 12 months
Change from baseline in diabetic retinopathy at 12 months
From enrollment until to the end of treatment at 12 months
Study Arms (2)
Montelukast
EXPERIMENTAL10 mg capsule by mouth daily
Placebo
PLACEBO COMPARATOROne matching capsule by mouth daily
Interventions
Eligibility Criteria
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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
University of Colorado Denver
Aurora, Colorado, 80045, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Jessica Kendrick, MD MPH
University of Colorado, Denver
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
June 29, 2026
First Posted
July 6, 2026
Study Start (Estimated)
September 1, 2026
Primary Completion (Estimated)
June 30, 2031
Study Completion (Estimated)
August 31, 2031
Last Updated
July 6, 2026
Record last verified: 2026-06
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL, SAP, ICF, CSR, ANALYTIC CODE
- 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.
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.