MIRACLE-T2D Montelukast Intervention for Renal, Cardiovas... | NCT07685886

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

NCT07685886

Sponsor

University of Colorado, Denver

Status

Not yet recruiting

Last Update Posted

Jul 6, 2026Actual

Enrollment

110Estimated

Phase

Phase 4

Conditions

Diabetes
Kidney Disease
Vascular Disease
Retinopathy

Interventions

Montelukast
Placebo

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jun 2026

Overall Recruitment Status or Expanded Access Status

Not yet recruiting

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Sep 1, 2026Estimated

Primary Completion Date

Jun 30, 2031Estimated

Completion Date

Aug 31, 2031Estimated

First Submitted Date

Jun 29, 2026

First Submission Date that Met QC Criteria

Jun 29, 2026

First Posted Date

Jul 6, 2026Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jun 29, 2026

Last Update Posted Date

Jul 6, 2026Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Yes

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Yes

FDAAA801 Violation

Not provided

Description Module

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.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 4

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

110Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Montelukast	Experimental	10 mg capsule by mouth daily	Drug: Montelukast
Placebo	Placebo Comparator	One matching capsule by mouth daily	Drug: Placebo

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Montelukast	Drug	10 my by mouth daily	Montelukast
Placebo

Outcomes Module

Primary Outcomes

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 Outcomes

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

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

80 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Jessica Kendrick, MD MPH	Contact	303-724-4837		jessica.kendrick@cuanschutz.edu

Overall Officials

Name	Affiliation	Role
Jessica Kendrick, MD MPH	University of Colorado, Denver	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
University of Colorado Denver		Aurora	Colorado	80045	United States

IPD Sharing Statement Module

Plan to Share IPD

Yes

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.

Types

Study Protocol
Statistical Analysis Plan (SAP)
Informed Consent Form (ICF)
Clinical Study Report (CSR)
Analytic Code

Time Frame

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D003920	Diabetes Mellitus
D007674	Kidney Diseases
D014652	Vascular Diseases
D012164	Retinal Diseases

Ancestor Terms

ID	Term
D044882	Glucose Metabolism Disorders
D008659	Metabolic Diseases
D009750	Nutritional and Metabolic Diseases
D004700	Endocrine System Diseases

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
C093875	montelukast

Ancestor Terms

Not provided

Browse Leaves

Not provided

Browse Branches

Not provided