RecruitingPhase 2NCT04530383

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

An Open Label Clinical Trial of Metformin in Those With CFRD on CFTR Modulator Therapy to Improve Ion Channel Function

Sponsor

University of Kansas Medical Center

Enrollment

30 participants

Start Date

Feb 14, 2022

Study Type

INTERVENTIONAL

Conditions

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)

Min Age: 18 Years

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)

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

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DRUGMetformin Hydrochloride

1000 mg twice daily

University of Kansas Medical Center

Kansas City, Kansas, United States

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NCT04530383