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

Korábbi kezelés

• Prior lung or liver transplant
• Systemic corticosteroid or regular non-steroidal anti-inflammatory use in the preceding 30 days
• Taking medications that interact with metformin.
• Use of medications known to be strong CYP inducers or moderate to strong CYP inhibitors

Laborértékek

• 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
• 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

Életkor

• Inability or unwillingness to comply with an approved contraceptive method during the study period (females of childbearing age)

Egyéb

• Use of supplemental oxygen
• BMI <18
• CF pulmonary exacerbation requiring hospitalization or intravenous antibiotics in the preceding 30 days
• Vitamin B12 deficiency
• Pregnancy or lactation
• Participation in another interventional trial that, in the opinion of the investigator, has the potential to affect the primary outcome

• 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)