Formoterol in Diabetes

Launched by MEDICAL UNIVERSITY OF SOUTH CAROLINA · Jun 6, 2025

Keywords

ClinConnect Summary

This clinical trial, called "Formoterol in Diabetes," is looking at whether a medication called formoterol fumarate can help patients with type 2 diabetes who also have chronic kidney disease (CKD) and a specific condition called diabetic nephropathy. The trial will compare the effects of formoterol to a placebo (a treatment that doesn’t have any active medication) to see if it’s feasible for a larger study in the future. Participants will receive either the medication or the placebo twice a day using a nebulizer, which is a device that turns liquid medicine into a mist for easy inhalation.

To be eligible for this trial, participants need to be adults between 18 and 75 years old with a diagnosis of type 2 diabetes and specific kidney disease markers. They should have stable medical treatment for at least three months and meet certain health criteria, such as having specific levels of kidney function and blood sugar control. If you or a loved one are interested, keep in mind that this study is not yet recruiting participants, and those involved will need to follow a set schedule and meet certain health requirements. It’s a chance to contribute to research that could improve treatment for people with diabetes-related kidney issues.

Gender

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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 disease as per the treating 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)
• • Maintenance of all additional anti-HTN medications, insulin, oral and injectable non-insulin agents and cholesterol lowering medications prior to randomization
• • Willing and able to comply with schedule of events and protocol requirements, including written informed consent.
• Exclusion Criteria:
• • on-diabetic kidney disease
• • Type 1 diabetes
• • 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 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