Formoterol in Diabetes
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18-75
SponsorMedical University of South Carolina
About this trial
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.
Eligibility criteria
Qualifiers
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
Disqualifiers
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
Trial design
Treatments tested in this trial
- Formoterol furmarate (20 μg)
Treatment groups
120 Participants
are divided into 2 treatment groupsSponsors and collaborators
Medical University of South Carolina
Lead sponsor
Dialysis Clinic, Inc.
Collaborator
Source ClinicalTrials.gov