Diabetes drug metformin may boost lung function in CF patients
NCT ID NCT04530383
First seen Jun 24, 2026 · Last updated Jun 27, 2026 · Updated 2 times
Summary
This phase 2 trial is testing whether metformin, a common diabetes drug, can improve airway function in 30 adults with cystic fibrosis-related diabetes who are already on CFTR modulator therapy. Researchers will measure changes in ion channel activity in nasal cells. The study aims to see if metformin can help control both blood sugar and lung health.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- Metformin (Glucophage)
- What this could lead to
- If it works, this could point toward a way to improve lung function in people with cystic fibrosis-related diabetes.
- What could go wrong
- This is a small, early-phase trial with only 30 participants, so results may not apply to everyone. Metformin can cause side effects like stomach upset.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 2
Tests whether the treatment actually works, and watches for side effects, in a larger group.
- Participants
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About 30 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Feb 2022
- Expected to finish
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Jul 2028
An estimate. End dates often move.
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 years and older
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion criteria: 1. Age \>18 years with a prior diagnosis of CF. 2. Use of ivacaftor or elexacaftor/tezacaftor/ivacaftor or vanzacaftor/tezacaftor/deutivacaftor for 30 days prior to day 0 3. Diagnosis of CFRD with evidence of continued glucose intolerance at least 6 months after starting qualifying modulator therapy will be based upon one of the following: 1. Insulin use 2. Hemoglobin A1C \>6.5% 3. Fasting glucose \>126 mg/dl 4. Non-fasting glucose \>200 mg/dl (random or as part of a 2-hr OGTT) Exclusion criteria: 1. Prior lung or liver transplant 2. Use of supplemental oxygen 3. BMI \<18 4. CF pulmonary exacerbation requiring hospitalization or intravenous antibiotics in the preceding 30 days 5. Systemic corticosteroid or regular non-steroidal anti-inflammatory use in the preceding 30 days 6. Cardiac, renal (creatinine clearance \<45 mL/minute), neurologic, psychiatric, endocrine or neoplastic diseases that are judged to interfere with participation in the study 7. Alanine aminotransferase, aspartate aminotransferase or alkaline phosphatase \>1.5X the upper limit of normal; bilirubin \>3 mg/dL 8. Taking medications that interact with metformin. 9. Vitamin B12 deficiency 10. Pregnancy or lactation 11. Inability or unwillingness to comply with an approved contraceptive method during the study period (females of childbearing age) 12. Use of medications known to be strong CYP inducers or moderate to strong CYP inhibitors 13. In the opinion of the investigator any severe or acute or chronic condition or laboratory abnormality that may increase the risk associated with trial participation or make the subject inappropriate for enrollment 14. Participation in another interventional trial that, in the opinion of the investigator, has the potential to affect the primary outcome
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The places running it
1 site. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
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University of Kansas Medical Center
RECRUITINGKansas City, Kansas, 66160, United States
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- Can a special lung scan catch cystic fibrosis damage earlier than standard tests?
- Can a pill replace the liquid? testing a new form of cystic fibrosis drug