Actively Recruiting
An Open Label Clinical Trial of Metformin to Improve Ion Channel Function in Adults With Cystic Fibrosis-related Diabetes on CFTR Modulator Therapy
Led by University of Kansas Medical Center · Updated on 2026-04-15
30
Participants Needed
1
Research Sites
28 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are investigating the use of metformin to improve airway ion channel function in adults with cystic fibrosis-related diabetes (CFRD) who are already receiving highly effective CFTR modulator therapy. This Phase 2 clinical trial aims to assess how metformin affects specific gene expressions and lung function measures related to cystic fibrosis and diabetes. The study is sponsored by the University of Kansas Medical Center and focuses on participants who continue to experience glucose intolerance despite modulator treatment. Participants will take metformin with a dose escalation starting at 500 mg twice daily for one week, then 500 mg in the morning and 1000 mg in the evening for another week, followed by 1000 mg twice daily for 14 weeks. To reduce the risk of vitamin B12 deficiency, a known side effect of long-term metformin use, all participants will also receive daily oral cyanocobalamin supplements throughout the study. This open-label trial involves a single treatment group receiving the study drug. During the 14-week treatment period, participants will undergo tests to measure changes in BK channel gene expression, nasal potential difference, receptor for advanced glycation end products (RAGE) gene expression, advanced glycation end products (AGE), sweat chloride levels, lung function, quality of life, and airway inflammation. Safety and pharmacokinetics of metformin will also be monitored. These assessments will help researchers understand the effects of metformin on airway ion channel function in this population.
CONDITIONS
Brief Title
Metformin for People With CFRD on CFTR Modulator Therapy to Improve Ion Channel Function
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age over 18 years with a prior diagnosis of cystic fibrosis
- Use of ivacaftor, elexacaftor/tezacaftor/ivacaftor, or vanzacaftor/tezacaftor/deutivacaftor for at least 30 days before starting the study
- Diagnosis of cystic fibrosis-related diabetes with ongoing glucose intolerance at least 6 months after starting modulator therapy, shown by insulin use, Hemoglobin A1C over 6.5%, fasting glucose over 126 mg/dl, or non-fasting glucose over 200 mg/dl
- Agreement to participate in the study
You will not qualify if you...
- Prior lung or liver transplant
- Use of supplemental oxygen
- Body mass index (BMI) less than 18
- Recent cystic fibrosis lung exacerbation requiring hospitalization or intravenous antibiotics within 30 days
- Use of systemic corticosteroids or regular non-steroidal anti-inflammatory drugs within 30 days
- Significant cardiac, kidney, neurologic, psychiatric, endocrine, or cancer conditions interfering with study participation
- Liver enzyme levels over 1.5 times normal or bilirubin over 3 mg/dL
- Use of medications that interact with metformin
- Vitamin B12 deficiency
- Pregnancy or breastfeeding
- Inability or unwillingness to use approved contraception during the study (for females of childbearing age)
- Use of strong CYP inducers or moderate to strong CYP inhibitors
- Any severe or acute condition making participation unsafe
- Participation in another interventional trial that could affect the main study outcome
AI-Screening
AI-Powered Screening
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Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - 16 weeks
Participants take metformin with a dose-escalation starting with 500mg twice daily for 1 week, followed by 500mg in the AM and 1000mg in the PM for 1 week, then 1000mg twice daily for 14 weeks, along with a daily vitamin B12 supplement to minimize risk of deficiency.
Multiple visits during the 16 weeks of treatment
Trial Site Locations
Total: 1 location
1
University of Kansas Medical Center
Kansas City, Kansas, United States, 66160
Actively Recruiting
Research Team
M
Matthias A Salathe, M.D.
C
Carolina Aguiar
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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