Formoterol for Diabetic Kidney Disease

Overseen By Recruitment Contact

Age: 18+

Sex: Any

Trial Phase: Phase 2

Sponsor: Medical University of South Carolina

Must be taking: ACE inhibitors, ARBs, SGLT inhibitors

Must not be taking: Beta-agonists

Disqualifiers: Pregnancy, Heart failure, Asthma, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: 40

Duration: 36 weeks

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests whether formoterol fumarate, an inhaled medication, can help treat diabetic kidney disease. Participants will either continue their usual treatment or add formoterol fumarate. The goal is to determine if formoterol fumarate can improve kidney health in people with type 2 diabetes. Ideal candidates have type 2 diabetes with kidney issues, have been on stable medication for at least three months, and do not have a history of asthma or certain heart problems. As a Phase 2 trial, this research measures the treatment's effectiveness in an initial, smaller group, offering participants a chance to contribute to important medical advancements.

Will I have to stop taking my current medications?

No, you will not have to stop taking your current medications. The trial allows participants to continue their standard treatments, including medications for diabetes and blood pressure, as long as they have been stable for at least 3 months.

Is there any evidence suggesting that formoterol fumarate is likely to be safe for humans?

Research has shown that formoterol fumarate, a medication often used in asthma inhalers, is generally safe. Its use for other health issues further supports its safety profile.

In past studies on asthma, some participants experienced side effects such as shaking, headaches, or a fast heartbeat. These side effects are usually mild and resolve on their own. Serious side effects are rare.

As this trial is in the early stages, some safety information is available, but more research is needed specifically for diabetic kidney disease. Participants should always consult their doctor if they have any concerns. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising for diabetic kidney disease?

Unlike the standard treatments for diabetic kidney disease, which typically include medications like ACE inhibitors and ARBs to manage blood pressure and reduce protein in urine, Formoterol Fumarate is unique because it uses a different approach. Formoterol is primarily a bronchodilator, but researchers are excited about its potential new role in kidney disease due to its anti-inflammatory properties and ability to improve blood flow. This treatment is administered via inhalation, offering a novel delivery method that targets the lungs directly, which could potentially reduce inflammation and improve kidney function. This new mechanism of action and administration route could offer additional benefits beyond traditional treatments.

What evidence suggests that formoterol fumarate might be an effective treatment for diabetic kidney disease?

Research has shown that formoterol fumarate, a type of medication, may improve kidney function in people with diabetic kidney disease. Studies in both mice and humans suggest that this drug can repair metabolic problems in the kidney's filtering units, which diabetes often damages. Early results are promising; formoterol appears to restore important cell functions that diabetes disrupts. In this trial, participants will receive either standard care treatment alone or formoterol fumarate in addition to standard care. Although human studies are limited, the drug's ability to target specific kidney issues offers hope for treating diabetic kidney disease. ^{1 2 3 6 7}

Who Is on the Research Team?

Joshua Lipschutz, MD

Principal Investigator

Medical University of South Carolina

Are You a Good Fit for This Trial?

This trial is for individuals with diabetic kidney disease who are currently receiving standard care treatment. Specific eligibility criteria details are not provided, but typically participants would need to meet certain health standards and agree to the study's procedures.

Inclusion Criteria

I am between 18 and 75 years old.

I have been on a stable dose of ACE inhibitor, ARB, or SGLT inhibitor for at least 3 months.

My kidney disease is related to diabetes, as confirmed by my kidney doctor.

Exclusion Criteria

My blood pressure is not higher than 150/95 mmHg.

Being involuntarily incarcerated

Patients with serum potassium levels <3.5 mEQ/L

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive formoterol fumarate or standard of care treatment for diabetic kidney disease

36 weeks

Visits at 0, 12, 24, 36 weeks

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

Visits at 40 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Formoterol furmarate

Trial Overview

The trial is testing if adding Formoterol fumarate (20 μg) to standard diabetes care can help treat diabetic kidney disease. Participants have an equal chance of being randomly assigned to receive either this additional medication or continue with their usual treatment only.

How Is the Trial Designed?

Group I: Formoterol Fumarate + Standard of Care Treatment Experimental Treatment 1 Intervention

Formoterol Fumarate Inhalation Solution as one 20 mcg unit-dose vial administered twice daily (morning and evening) by nebulization (in addition to standard of care treatment)

Group II: Standard of Care Only Active Control 1 Intervention

Standard of Care Treatment Only

Who Is Running the Clinical Trial?

Medical University of South Carolina

Lead Sponsor

Trials

994

Recruited

7,408,000+

Dialysis Clinic, Inc.

Industry Sponsor

Trials

24

Recruited

11,800+

Citations

1.

clinicaltrials.gov

clinicaltrials.gov/study/NCT07022418

Study Details | NCT07022418 | Formoterol in Diabetes

The purpose of the study is to evaluate if formoterol fumarate is effective in treating patients with diabetic kidney disease. Study participants will be ...

2.

ctv.veeva.com

ctv.veeva.com/study/formoterol-in-diabetes

Formoterol in Diabetes - ClinicalTrials.Veeva

The purpose of the study is to evaluate if formoterol fumarate is effective in treating patients with diabetic kidney disease.

3.

researchgate.net

researchgate.net/publication/395502312_The_b2-Adrenoceptor_Agonist_Formoterol_Reverses_Metabolic_Dysfunction_in_the_Diabetic_Proximal_Tubule

The β2-Adrenoceptor Agonist Formoterol Reverses ...

Unraveling the nexus of NAD+ metabolism and diabetic kidney disease: insights from murine models and human data. Article. Full-text available.

4.

withpower.com

withpower.com/clinical-trials/for-diabetic-kidney-disease

Top Diabetic Kidney Disease Clinical Trials | Power

The purpose of the study is to evaluate if formoterol fumarate is effective in treating patients with diabetic kidney disease. Study participants will be ...

5.

publications.ersnet.org

publications.ersnet.org/content/erjor/early/2025/07/03/23120541.00324-2025.full.pdf

Effect of budesonide/glycopyrronium/formoterol fumarate ...

▫ History of diabetes mellitus. ▫ History of chronic kidney disease, with eGFR ≥20 mL/min/1.73 m2 and <60 mL/min/1.73 m2 confirmed at ...

6.

pmc.ncbi.nlm.nih.gov

pmc.ncbi.nlm.nih.gov/articles/PMC5871636/

New Diabetes Therapies and Diabetic Kidney Disease ...

SGLT-2 inhibitors may improve renal oxygenation and intra-renal inflammation thereby slowing the progression of kidney function decline.

7.

go.drugbank.com

go.drugbank.com/drugs/DB00983

Formoterol: Uses, Interactions, Mechanism of Action

Improve decision support & research outcomes with our structured adverse effects data. See a data sample. Toxicity ... Diabetic Kidney Disease (DKD) / Diabetic ...