Actively Recruiting
Formoterol in Diabetes
Led by Medical University of South Carolina · Updated on 2026-02-05
120
Participants Needed
1
Research Sites
100 weeks
Total Duration
On this page
Sponsors
M
Medical University of South Carolina
Lead Sponsor
D
Dialysis Clinic, Inc.
Collaborating Sponsor
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Formoterol in Diabetes
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Adults aged 18-75
- Diagnosis of type 2 diabetes according to American Diabetes Association criteria
- On stable medical therapy for at least 3 months
- Stage CKD G2 to G3b; A2-A3 as defined by eGFR without needing renal biopsy
- Diagnosis of diabetic kidney disease confirmed by a nephrologist
- Urinary albumin to creatinine excretion rate between 200-5000 mg/g/24hrs on at least two occasions (one can be a spot test)
- HbA1c less than 8%
- Receiving stable doses of ACE inhibitor or ARB therapy for at least 3 months prior (unless contraindicated) and/or stable dose of SGLT inhibitor for at least 3 months
- Stable doses of other blood pressure, diabetes, and cholesterol medications for at least 3 months prior (unless contraindicated)
- Willing and able to comply with study schedule and provide informed consent
You will not qualify if you...
- Female participants who are pregnant, breastfeeding, or planning pregnancy
- Currently taking beta-agonists
- Organ transplant recipients
- History of NYHA class III/IV heart failure or serious heart problems (CABG, stroke, MI) within past 12 months
- History of asthma
- Serum potassium levels below 3.5 mEQ/L
- Uncontrolled hypertension with systolic BP over 150 mmHg or diastolic BP over 95 mmHg
- EKG showing QTc prolongation or tachyarrhythmia including sinus tachycardia over 100 bpm
- Known allergy or hypersensitivity to formoterol fumarate, ACE inhibitors, or ARBs
- Advanced organ failure
- Untreated or uncontrolled cardiovascular, lung, or gastrointestinal diseases
- BMI over 50
- Active untreated cancer
- Alcohol or drug abuse within past 6 months
- Involuntary incarceration
- Participation in another interventional clinical trial
- Unable or unwilling to complete the 36-week intervention
AI-Screening
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Trial Site Locations
Total: 1 location
1
Medical University of South Carolina
Charleston, South Carolina, United States, 29425
Actively Recruiting
Research Team
R
Recruitment Contact
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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