No Placebo Group
Every participant receives an active treatment — no one gets a placebo.
Prior Safety Data
This treatment has already been tested in at least one earlier human trial.
Ready to participate?
Review the details below, then apply to join this clinical trial.
At a Glance
Age
18 – 75
Sex
Any
Trial phase
Phase 2
Study type
Interventional
Purpose
Treatment
Participants needed
120 (estimated)
Sponsor
Medical University of South Carolina · Other
Who this trial is looking for
This trial is looking for adults with type 2 diabetes and diabetic kidney disease. Participants will either receive an additional treatment called formoterol or continue with their current treatments as usual.
Are You a Good Fit for This Trial?
Must be takingACE inhibitorsARB therapySGLT inhibitors
Rules you outAdvanced organ failureActive untreated cancerBMI over 50Alcohol or drug abuse in the past 6 months
You may be able to join if
I am between 18 and 75 years old.
I have been diagnosed with type 2 diabetes.
I have been on stable medical therapy for at least 3 months.
I have diabetic kidney disease confirmed by a nephrologist.
I have a urine test showing 200-5000 mg of albumin per gram of creatinine.
My HbA1c is less than 8%.
I have been taking stable doses of medication for high blood pressure for at least 3 months.
I can comply with the study requirements and give written consent.
You may not be able to join if
I am pregnant or breastfeeding.
I currently take beta-agonist medications.
I have had serious heart problems in the last year.
I have a history of asthma.
My potassium levels are low.
I have uncontrolled high blood pressure.
I cannot take formoterol due to allergies.
I have untreated cancer.
Summarized in plain language from this trial's official eligibility criteria.
The full criteria are further down this page — only the research team can
confirm whether you qualify.
Think this trial could be right for you?
Answer three quick questions written from this study's own rules to see if you may qualify. No account needed to find out.
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 n…
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.
Trial Locations
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Eligibility Criteria
Inclusion Criteria:
* 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 dis…
Inclusion Criteria:
* 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.
Exclusion Criteria:
* Female subjects who are pregnant or breast feeding or who plan on becoming pregnant
* Currently take beta-agonists
* Organ transplant recipients
* 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
* Patients with serum potassium levels \<3.5 mEQ/L
* Patients with uncontrolled HTN SBP \>150mmHg, DBP \>95mmHg
* EKG showing QTc elongation or tachyarrhythmia; including sinus tachycardia \>100bpm
* 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
* Patients with BMI \>50
* Active untreated cancer
* Alcohol or drug abuse in the past 6 months
* Being involuntarily incarcerated
* Participating in another interventional study
* Unable or unwilling to do the 36-week intervention
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