Formoterol in Diabetes

NCT07022418 | Recruiting Phase 2 DMC FDA Drug

• 1 other identifier: Pro00144030
• Study Type: interventional
• Target: 120
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Diabetic Kidney Disease; Diabetic Nephropathies

Keywords

Diabetes

Outcome Measures

Primary Outcomes (4)

• Feasibility: refusal rate and adherence during the 36-week treatment

  The primary measures of feasibility will be study refusal rate and adherence during the 36-week treatment. Refusal rate will be the percentage of individuals who are offered the opportunity to enroll but choose not to accept it. Adherence will be defined as the proportion of doses taken during the 36-week treatment period. For patients who fail to complete the study, adherence will be estimated as the number of doses they report taking for visits at which they are present over the total number of doses they should have received.

  36 weeks

• To assess the safety, tolerability, and acceptability of the intervention with formoterol

  Rates of adverse events and safety measures will be compared between groups. The investigators will assess adherence with the intervention and study medication.

  36 Weeks

• To perform preliminary efficacy testing and determine the variability of albuminuria

  Changes in albuminuria will be compared between groups to provide preliminary efficacy testing.

  36 Weeks

• To perform preliminary efficacy testing and determine the variability of eGFR.

  Changes in eGFR will be compared between groups to provide preliminary efficacy testing. eGFR will be assessed using the CKD-Epi Formula.

  36 Weeks

Secondary Outcomes (14)

• Safety Monitoring: Body Weight

  36 Weeks

• EKG Evaluations

  40 Weeks

• Adherence

  36 Weeks

• Adverse Events

  40 Weeks

• Tolerability and acceptability

  32 Weeks

Study Arms (2)

Standard of Care Only

NO INTERVENTION

Standard of Care Treatment Only

Formoterol Fumarate + Standard of Care Treatment

EXPERIMENTAL

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)

Drug: Formoterol furmarate (20 μg)

Interventions

Formoterol furmarate (20 μg) DRUG

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.

Formoterol Fumarate + Standard of Care Treatment

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Medical University of South Carolina: lead
• Dialysis Clinic, Inc.: collaborator

Study Sites (1)

Medical University of South Carolina

Charleston, South Carolina, 29425, United States

RECRUITING

MeSH Terms

Conditions

Diabetic Nephropathies; Diabetes Mellitus

Condition Hierarchy (Ancestors)

Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Diabetes Complications; Endocrine System Diseases; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases

Study Officials

• Joshua Lipschutz, MD

  Medical University of South Carolina

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Recruitment Contact

CONTACT

(843) 792-0965; recruitment@musc.edu

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor-Faculty

Study Record Dates

• First Submitted: May 21, 2025
• First Posted: June 15, 2025
• Study Start: December 1, 2025
• Primary Completion (Estimated): December 1, 2026
• Study Completion (Estimated): November 1, 2027
• Last Updated: February 5, 2026

Record last verified: 2025-11

Locations

US (1)