Actively Recruiting

Phase 2
Age: 18Years +
All Genders
NCT04530383

Metformin for People With CFRD on CFTR Modulator Therapy to Improve Ion Channel Function

Led by University of Kansas Medical Center · Updated on 2026-04-15

30

Participants Needed

1

Research Sites

334 weeks

Total Duration

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AI-Summary

What this Trial Is About

The purpose of this study is to assess the efficacy of metformin to improve airway ion channel function in those with CF-related diabetes (CFRD)

CONDITIONS

Official Title

Metformin for People With CFRD on CFTR Modulator Therapy to Improve Ion Channel Function

Who Can Participate

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Age over 18 years with prior diagnosis of cystic fibrosis
  • Use of ivacaftor, elexacaftor/tezacaftor/ivacaftor, or vanzacaftor/tezacaftor/deutivacaftor for at least 30 days before starting
  • Diagnosis of cystic fibrosis-related diabetes with ongoing glucose intolerance at least 6 months after starting modulator therapy, confirmed by insulin use, hemoglobin A1C over 6.5%, fasting glucose over 126 mg/dl, or non-fasting glucose over 200 mg/dl
Not Eligible

You will not qualify if you...

  • Prior lung or liver transplant
  • Use of supplemental oxygen
  • Body mass index under 18
  • Cystic fibrosis lung flare requiring hospitalization or IV antibiotics within last 30 days
  • Use of systemic corticosteroids or regular non-steroidal anti-inflammatory drugs in last 30 days
  • Cardiac, kidney (creatinine clearance under 45 mL/min), neurological, psychiatric, endocrine, or cancer conditions interfering with study
  • Elevated liver enzymes or bilirubin above specified limits
  • Taking medications that interact with metformin
  • Vitamin B12 deficiency
  • Pregnancy or breastfeeding
  • Inability or unwillingness to use approved birth control during study (for women of childbearing age)
  • Use of strong CYP inducers or moderate to strong CYP inhibitors
  • Any severe or acute or chronic condition or lab abnormality increasing trial risk or inappropriate for enrollment
  • Participation in another interventional trial affecting the primary outcome

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 1 location

1

University of Kansas Medical Center

Kansas City, Kansas, United States, 66160

Actively Recruiting

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Research Team

M

Matthias A Salathe, M.D.

CONTACT

C

Carolina Aguiar

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

NA

Model

SINGLE_GROUP

Primary Purpose

TREATMENT

Number of Arms

1

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