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

Trial statusNot yet recruiting
Trial phasePhase 4
Trial typeInterventional
Biological sexAll
Age18-80
SponsorUniversity of Colorado, Denver

About 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.

Eligibility criteria

Qualifiers

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

Disqualifiers

Type 1 diabetes

Uncontrolled hypertension

Hemoglobin A1C >10%

Pregnancy or planning to become pregnant or currently breastfeeding

Trial design

Treatments tested in this trial

  • Montelukast
  • Placebo

Treatment groups

110 Participants
are divided into 2 treatment groups

Sponsors and collaborators