DiabetesPhase 4MIRACLE-T2DNCT07685886
MIRACLE-T2D Montelukast Intervention for Renal, Cardiovascular and Eye Health in Type 2 Diabetes
A Phase 4 study testing Montelukast in people with Diabetes and Kidney Disease, run by University of Colorado, Denver at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Diabetes, Kidney Disease, Vascular Disease
- What is being tested?
- Montelukast
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 110 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Sep 2026to 31 Aug 2031
- Phase
- Phase 4
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site
University of Colorado Denver
Aurora, Colorado, 80045
Jessica Kendrick, 303-724-4837, jessica.kendrick@cuanschutz.edu
jessica.kendrick@cuanschutz.edu
About this study
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.
- Conditions
- Diabetes, Kidney Disease, Vascular Disease, Retinopathy
- Being tested
- Montelukast, Placebo
- Medical subject headings
- Diabetes Mellitus, Kidney Diseases, Vascular Diseases, Retinal Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MontelukastDrug
10 my by mouth daily
PlaceboDrug
One capsule by mouth daily
| Study group | Role | What they receive |
|---|---|---|
| Montelukast | Experimental | 10 mg capsule by mouth daily Receives: Drug: Montelukast |
| Placebo | Placebo comparator | One matching capsule by mouth daily Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from baseline in urine albumin excretion at 12 months
24-hour urine albumin
Measured: From enrollment to the end of treatment at 12 months
Secondary outcomes (4)
Change from baseline in creatinine clearance at 12 months
Measured: 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
Measured: 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
Measured: From enrollment until end of treatment at 12 months
Change from baseline in diabetic retinopathy at 12 months
Measured by OCTA
Measured: From enrollment until to the end of treatment at 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Jul 2026
- Study start1 Sep 2026 (estimated)
- Primary completion30 Jun 2031 (estimated)
- Study completion31 Aug 2031 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for DiabetesStudies of the same condition, open and under way.
- More trials run by University of Colorado, DenverThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 110 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Colorado, Denver
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Jessica Kendrick, MD MPH, Principal investigator, University of Colorado, Denver
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07685886
- Sponsor's protocol ID
- 26-1415
- Acronym
- MIRACLE-T2D
- Status last verified
- Jun 2026
- First submitted
- 29 Jun 2026
- Last updated
- 6 Jul 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: 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.
Study at a glance
From the registry record, last updated by the sponsor on 6 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- MIRACLE-T2D Montelukast Intervention for Renal, Cardiovascular and Eye Health in Type 2 Diabetes
- ClinicalTrials.gov ID
- NCT07685886
- Acronym / sponsor ID
- MIRACLE-T2D / 26-1415
- Conditions
- Diabetes, Kidney Disease, Vascular Disease, Retinopathy
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 110 participants (estimated)
- Lead sponsor
- University of Colorado, DenverUniversity, hospital or other
- Study start
- 1 Sep 2026 (estimated)
- Primary completion
- 30 Jun 2031 (estimated)
- Study completion
- 31 Aug 2031 (estimated)
- First posted
- 6 Jul 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Montelukast | Experimental | Drug: Montelukast10 mg capsule by mouth daily |
| Placebo | Placebo comparator | Drug: PlaceboOne matching capsule by mouth daily |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- 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
Key exclusion criteria (8 listed)
- Type 1 diabetes
- Uncontrolled hypertension
- Hemoglobin A1C >10%
- Pregnancy or planning to become pregnant or currently breastfeeding
- Allergy to aspirin
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Montelukast10 my by mouth daily | Drug | Montelukast |
| PlaceboOne capsule by mouth daily | Drug | Placebo |
Primary outcome
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
4 secondary outcomes
Change from baseline in creatinine clearance at 12 months
Time frame: From time of enrollment until end of treatment at 12 months
Change from baseline in vascular endothelial function at 12 months
Time frame: From enrollment to the end of treatment at 12 months
Change from baseline in arterial stiffness at 12 months
Time frame: From enrollment until end of treatment at 12 months
Change from baseline in diabetic retinopathy at 12 months
Time frame: From enrollment until to the end of treatment at 12 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Jul 2026.
- Individual participant dataSharing planned: Yes. 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.
Related trials for Diabetes
Not yet recruitingPhase 3
Efficacy and Safety of Once-Weekly SHR-3167 Compared With Once-Daily Insulin Glargine in Adults With Insulin-Naive Type 2 Diabetes
Type 2 Diabetes
Active, not recruiting
Digital Reinforcement of Motivational Interviewing Micro-Skills Among Primary Care Healthcare Professionals
Hypertension (Without Type 2 Diabetes Mellitus)
Recruiting
Effects of Lean Pork Loin Intake on Protein Homeostasis and Glucose Regulation in Prediabetic Adults
Hyperglycaemia (Non Diabetic), Prediabetes
Recruiting
PAW-Hydrogel for Chronic Wound Healing
Diabetic Foot Ulcer (DFU), Pressure Ulcer (PU)
Recruiting
Investigating Vascular Properties of HEMI and SPG Signals in Individuals With or at Risk for Chronic Kidney Disease
Chronic Kidney Disease, Hypertension (HTN)
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Jessica Kendrick, MD MPH principal investigator
University of Colorado, Denver
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Montelukast in people with Diabetes and Kidney Disease, run by University of Colorado, Denver at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 6 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Jessica Kendrick, MD MPH (303-724-4837, jessica.kendrick@cuanschutz.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change from baseline in urine albumin excretion at 12 months (time frame: From enrollment to the end of treatment at 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Jul 2026.