NCT07022418RecruitingPhase 2
Formoterol in Diabetes
Prospective Randomized Pilot Trial of Formoterol in Patients With Diabetic Kidney Disease
Source: ClinicalTrials.gov · Last updated 5 Feb 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Phase (registry)
- Phase 2
- Study type
- Interventional
- Enrollment
- 120 (estimated)
- First submitted
- 21 May 2025
- Start date
- 1 Dec 2025
- Primary completion date
- Dec 2026
- Lead sponsor
- Medical University of South Carolina
- Diseases
- Chronic kidney disease
- NCT number
- NCT07022418
What you commit to
- Study type: Interventional · Phase 2
- Planned participants: 120
- From 1 Dec 2025 to the primary completion date, Dec 2026
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Organ transplant recipients
- Alcohol or drug abuse in the past 6 months
Other illness
- Any history of New York Heart Association (NYHA) class III/IV heart failure or recent history of serious heart problem (CABG, stroke, MI) in the past 12 months
- Any history of asthma
- Contraindications to formoterol fumarate (hypersensitivity, including patients with known hypersensitivity to ACE inhibitors or ARBs)
- Advanced organ failure
- Untreated/uncontrolled cardiovascular, pulmonary, or gastrointestinal disease
- Active untreated cancer
Lab values
- Patients with serum potassium levels \<3.5 mEQ/L
- EKG showing QTc elongation or tachyarrhythmia; including sinus tachycardia \>100bpm
Other
- Female subjects who are pregnant or breast feeding or who plan on becoming pregnant
- Currently take beta-agonists
- Patients with uncontrolled HTN SBP \>150mmHg, DBP \>95mmHg
- Patients with BMI \>50
- Being involuntarily incarcerated
- Participating in another interventional study
- Unable or unwilling to do the 36-week intervention
Who the study is looking for
- Adults aged 18-75
- Diagnosis of type 2 diabetes according to American Diabetes Association (ADA) criteria
- On stable medical therapy for at least 3 months
- Stage CKD G2 to G3b; A2-A3 as defined by eGFR with no requirement for renal biopsy for diagnosis
- Diabetic kidney disease as per Nephrologist
- Urinary albumin to creatinine excretion rate (UACR) 200-5000 mg/g/24hrs on at least two occasions (one of these can be a spot UACR)
- HbA1c \<8%
- Receiving stable doses of ACE inhibitor or ARB therapy prior to screening (at least 3 months, unless contraindicated) and/or a stable dose of an SGLT inhibitor (at least 3 months preceding enrollment)
- Receiving stable doses of all additional anti-HTN medications, insulin, oral and injectable non-insulin agents and cholesterol lowering medications at least 3 months prior (unless contraindicated) to randomization and agree to maintain until the study's conclusion.
- Willing and able to comply with schedule of events and protocol requirements, including written informed consent.
Age in the registry: 18 years to 75 years · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Medical University of South Carolina Coordinator of this site? Confirm its status | Charleston | United States | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.