Montelukast for Type 2 Diabetes

(MIRACLE-T2D Trial)

JK
Overseen ByJessica Kendrick, MD MPH
Age: 18+
Sex: Any
Trial Phase: Phase 4
Sponsor: University of Colorado, Denver
Prior Safety DataThis treatment has passed at least one previous human trial

What You Need to Know Before You Apply

What is the purpose of this trial?

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.

Who Is on the Research Team?

JK

Jessica Kendrick, MD MPH

Principal Investigator

University of Colorado, Denver

Are You a Good Fit for This Trial?

This trial is for adults with type 2 diabetes who also have kidney disease. Participants should not have other major health issues that would prevent safe participation.

Inclusion Criteria

BMI less than or equal to 40 kg/m2
Urine albumin to creatinine ratio 30-5000 mg/g
I have been taking a stable dose of ACEi or ARB for at least 4 weeks.
See 5 more

Exclusion Criteria

Hemoglobin A1C greater than 10%
Pregnancy or planning to become pregnant or currently breastfeeding
Allergy to aspirin
See 5 more

What Are the Treatments Tested in This Trial?

Interventions

  • Montelukast

Trial Overview

The study tests whether montelukast, a medication usually used for asthma and allergies, can help protect the kidneys, eyes, and blood vessels in people with type 2 diabetes compared to a placebo (inactive pill).

How Is the Trial Designed?

2

Treatment groups

Experimental Treatment

Placebo Group

Group I: MontelukastExperimental Treatment1 Intervention
Group II: PlaceboPlacebo Group1 Intervention

Find a Clinic Near You

Who Is Running the Clinical Trial?

University of Colorado, Denver

Lead Sponsor

Trials
1,842
Recruited
3,028,000+