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Could an allergy drug shield diabetics from organ damage?

NCT ID NCT07685886

Disease control Sponsor: University of Colorado, Denver Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting This study
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jul 06, 2026 · Last updated Jul 07, 2026 · Updated 1 time

Summary

This study tests whether montelukast, a common allergy medication, can reduce damage to the kidneys, eyes, and blood vessels in adults with type 2 diabetes and early kidney disease. The drug works by blocking inflammatory chemicals called leukotrienes, which are linked to diabetes complications. Participants take either montelukast or a placebo daily for 12 months while researchers measure changes in kidney function, blood vessel health, and eye health.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
montelukast
What this could lead to
If it works, montelukast could become a new, affordable way to slow or prevent kidney, eye, and blood vessel damage in people with type 2 diabetes.
What could go wrong
This is a small, early-phase trial, so results may not apply to everyone. Montelukast is generally safe but may cause side effects like headache or digestive issues.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 4

Runs after approval, following long-term safety and how well the treatment works in everyday use.

Participants

About 110 people

The number the study aims to enrol. It can still change while the study runs.

Expected to start

Sep 2026

An estimate. Start dates often move.

Expected to finish

Aug 2031

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 to 80 years

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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

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Conditions

The condition(s) this trial relates to.

diabetes mellitus diabetic kidney disease impaired renal function disease kidney disorder retinal disorder type 2 diabetes mellitus vascular disorder

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Diabetes Kidney disease Retinopathy Vascular disease

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    1 site. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • University of Colorado Denver

    Aurora, Colorado, 80045, United States

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