RecruitingPhase 2

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

United States30 participantsStarted 2022-02-14

Plain-language summary

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)

Age range18 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

✓. 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.

Change in BK channel gene expression

Timeframe: Baseline through week 14 of metformin treatment

NCT IDNCT04530383

SponsorUniversity of Kansas Medical Center

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2027-12-30

Matthias A Salathe, M.D.

Who can participate

Age range18 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

✓. 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.