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

Recruiting now · Phase 2

Conditions studied: Cystic Fibrosis-related Diabetes, Cystic Fibrosis

In brief

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)

Key facts

Study ID

NCT04530383

Run by

University of Kansas Medical Center

People needed

30

Starts

2022-02-14

Expected to finish

2028-07-15

Last updated by the study team

2026-04-15

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Age >18 years with a prior diagnosis of CF.
• Use of ivacaftor or elexacaftor/tezacaftor/ivacaftor or vanzacaftor/tezacaftor/deutivacaftor for 30 days prior to day 0
• 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:
• Insulin use
• Hemoglobin A1C >6.5%
• Fasting glucose >126 mg/dl
• Non-fasting glucose >200 mg/dl (random or as part of a 2-hr OGTT)

You may not qualify if…

• Prior lung or liver transplant
• Use of supplemental oxygen
• BMI <18
• CF pulmonary exacerbation requiring hospitalization or intravenous antibiotics in the preceding 30 days
• Systemic corticosteroid or regular non-steroidal anti-inflammatory use in the preceding 30 days
• Cardiac, renal (creatinine clearance <45 mL/minute), neurologic, psychiatric, endocrine or neoplastic diseases that are judged to interfere with participation in the study
• Alanine aminotransferase, aspartate aminotransferase or alkaline phosphatase >1.5X the upper limit of normal; bilirubin >3 mg/dL
• Taking medications that interact with metformin.
• Vitamin B12 deficiency
• Pregnancy or lactation
• Inability or unwillingness to comply with an approved contraceptive method during the study period (females of childbearing age)
• Use of medications known to be strong CYP inducers or moderate to strong CYP inhibitors
• 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
• Participation in another interventional trial that, in the opinion of the investigator, has the potential to affect the primary outcome

Where it is running

• University of Kansas Medical Center — Kansas City, Kansas, United States (enrolling)

Full record on ClinicalTrials.gov

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