Effects of Metformin on Airway Ion Channel Dysfunction in Cystic Fibrosis-related Diabetes

• Status: Not yet recruiting
• Trial end date: 2025-10-01
• Target enrollment: 0
• Participant gender: All

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)

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: University of Kansas Medical Center
• Treatments: Metformin

Criteria

Inclusion criteria:

1. Age >18 years with a prior diagnosis of CF.

2. Use of ivacaftor or elexacaftor/tezacaftor/ivacaftor for 30 days prior to day 0

3. Diagnosis of CFRD with evidence of continued glucose intolerance since starting elexacaftor/tezacaftor/ivacaftor will be based upon one of the following:

1. Insulin use

2. Hemoglobin A1C >6.5%

3. Fasting glucose >126 mg/dl

4. Non-fasting glucose >200 mg/dl (random or as part of a 2-hr OGTT)

Exclusion criteria:

1. Prior lung or liver transplant

2. Use of supplemental oxygen

3. BMI <18

4. CF pulmonary exacerbation requiring hospitalization or intravenous antibiotics in the preceding 30 days

5. Use of supplemental oxygen.

6. Systemic corticosteroid or regular non-steroidal anti-inflammatory use in the preceding 30 days

7. Cardiac, renal (creatinine clearance <45 mL/minute), neurologic, psychiatric, endocrine or neoplastic diseases that are judged to interfere with participation in the study

8. Alanine aminotransferase, aspartate aminotransferase or alkaline phosphatase >1.5X the upper limit of normal; bilirubin >3 mg/dL

9. Taking medications that interact with metformin.

10. Vitamin B12 deficiency

11. Pregnancy or lactation

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

13. Use of medications known to be strong CYP inducers or moderate to strong CYP inhibitors

14. 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

15. Participation in another interventional trial that, in the opinion of the investigator, has the potential to affect the primary outcome