Formoterol in Diabetes

Part of paid clinical trials in Charleston, South Carolina.

Sponsor
Medical University of South Carolina
Study ID
NCT07022418
Phase
PHASE2
Status
Recruiting
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Conditions

  • Diabetic Kidney Disease
  • Diabetic Nephropathies

Eligibility Criteria

Sex
ALL
Age
18 Years - 75 Years
Healthy Volunteers
Not accepted

Interventions

  • Formoterol furmarate (20 μg) — DRUG
    Investigators chose to use the long-acting β2-AR agonist, formoterol, because of its efficacy and safety profile in patients with COPD and because formoterol showed the most association with protection from progression of CKD in our retrospective study.

Study Details

The purpose of the study is to evaluate if formoterol fumarate is effective in treating patients with diabetic kidney disease. Study participants will be randomly assigned to either receive formoterol fumarate (in addition to their current standard of care treatment) or standard of care treatment only. Study participants will have a 50% chance of receiving formoterol fumarate and a 50% chance of not receiving formoterol fumarate. Both groups will continue their standard of care treatment during the study. The primary goal is to gather data on feasibility and effect sizes to properly power a future clinical trial.

Key Dates

Start date
Dec 1, 2025
Status verified
Nov 2025
Primary completion
Dec 31, 2026
Completion
Nov 30, 2027

Study Design

Enrollment
120 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • No Intervention: Standard of Care Only
    Standard of Care Treatment Only
  • Experimental: Formoterol Fumarate + Standard of Care Treatment
    Formoterol Fumarate Inhalation Solution as one 20 mcg unit-dose vial administered twice daily (morning and evening) by nebulization (in addition to standard of care treatment)

Primary Outcome Measure

Feasibility: refusal rate and adherence during the 36-week treatment [ Time Frame: 36 weeks ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Medical University of South CarolinaCharlestonSouth Carolina29425
Recruitment
[email protected]
8437920965

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By research site
Medical University of South Carolina· Charleston, SC

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