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RECRUITING

NCT07022418

PHASE2

Formoterol in Diabetes

Sponsor: Medical University of South Carolina

View on ClinicalTrials.gov

Summary

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.

Official title: Prospective Randomized Pilot Trial of Formoterol in Patients With Diabetic Kidney Disease

Key Details

Gender

All

Age Range

18 Years - 75 Years

Study Type

INTERVENTIONAL

Enrollment

120

Start Date

2025-12-01

Completion Date

2027-11

Last Updated

2026-02-05

Healthy Volunteers

Conditions

Diabetic Nephropathies Diabetic Kidney Disease

Interventions

DRUG

Formoterol furmarate (20 μg)

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.

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

Locations (1)

Medical University of South Carolina

Charleston, South Carolina, United States