Not yet taking people in United StatesPhase 4

Tests montelukast in adults with type 2 diabetes and kidney disease

Tests montelukast against placebo for kidney, eye and blood vessel health in adults.

Key facts

Who runs it: University of Colorado, Denver
Where: Aurora, United StatesSee the site
Trial code: NCT07685886
Registry title: MIRACLE-T2D Montelukast Intervention for Renal, Cardiovascular and Eye Health in Type 2 Diabetes
Status: Not yet recruiting
Phase: Phase 4
People taking part: 110 people, planned
Started: 1 Sept 2026
Expected to end: 31 Aug 2031
Type of study: Interventional, 2 groupsOne group gets a placebo (a dummy treatment), for comparison.
Treatments tested: Montelukast
Placebo
Record updated: 6 July 2026

Who can take part

AI summary

From the trial's eligibility criteria. Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.

The trial is looking for adults with type 2 diabetes and mild to moderate kidney disease. It tests whether montelukast helps kidney, eye and blood vessel health.

Age: 18 to 80 years
Sex: All sexes can join.
Disease stage: Type 2 diabetes with chronic kidney disease stage 2-3 (eGFR 30-89 ml/min/1.73m2). Urine albumin to creatinine ratio 30-5000 mg/g. Blood pressure below 140/90 mmHg. BMI of 40 kg/m2 or less.
Earlier treatment: Must take an ACEi or ARB at a stable dose for 4 weeks. If taking an SGLT2i or GLP-1RA, the dose must be stable for 3 months before baseline. Cannot use inhaled or systemic corticosteroids or long-acting beta agonists.

Main reasons for not taking part

Type 1 diabetes
Uncontrolled high blood pressure
Hemoglobin A1C above 10% (86 mmol/mol)
Pregnant, planning pregnancy or breastfeeding
Allergy to aspirin

The registry criteria, word for word

Show all 16 criteriaShow less

Who can take part

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 take part

Use of inhaled or systemic corticosteroids or long-acting beta agonists
Type 1 diabetes
Uncontrolled hypertension
Allergy to aspirin
History of major psychiatric disorder
Hemoglobin A1C >10%
Pregnancy or planning to become pregnant or currently breastfeeding
Proliferative retinopathy requiring current treatment

Check if you might fit

Answer for yourself. This is not a decision: only the study team can say whether you can take part.

Are you between 18 and 80 years old?

Where in United States

University of Colorado DenverAurora, United StatesContact: Jessica KendrickNot yet recruiting

About the trial

What the trial wants to find out

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.