NCT04530383 Metformin for People With CFRD on CFTR Modulator Therapy to Improve Ion Channel Function
| NCT ID | NCT04530383 |
| Status | Recruiting |
| Phase | Phase 2 |
| Sponsor | University of Kansas Medical Center |
| Condition | Cystic Fibrosis-related Diabetes |
| Study Type | INTERVENTIONAL |
| Enrollment | 30 participants |
| Start Date | 2022-02-14 |
| Primary Completion | 2027-12-30 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
In Phase 2, researchers evaluate early signs of effectiveness. You may be randomized to receive the active treatment or a comparator. Monitoring continues closely.
This trial targets 30 participants in total. It began in 2022-02-14 with a primary completion date of 2027-12-30.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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)
Eligibility Criteria
Inclusion criteria: 1. Age \>18 years with a prior diagnosis of CF. 2. Use of ivacaftor or elexacaftor/tezacaftor/ivacaftor or vanzacaftor/tezacaftor/deutivacaftor for 30 days prior to day 0 3. 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: 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. Systemic corticosteroid or regular non-steroidal anti-inflammatory use in the preceding 30 days 6. Cardiac, renal (creatinine clearance \<45 mL/minute), neurologic, psychiatric, endocrine or neoplastic diseases that are judged to interfere with participation in the study 7. Alanine aminotransferase, aspartate aminotransferase or alkaline phosphatase \>1.5X the upper limit of normal; bilirubin \>3 mg/dL 8. Taking medications that interact with metformin. 9. Vitamin B12 deficiency 10. Pregnancy or lactation 11. Inability or unwillingness to comply with an approved contraceptive method during the study period (females of childbearing age) 12. Use of medications known to be strong CYP inducers or moderate to strong CYP inhibitors 13. 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 14. Participation in another interventional trial that, in the opinion of the investigator, has the potential to affect the primary outcome
Contact & Investigator
Matthias A Salathe, M.D.
PRINCIPAL INVESTIGATOR
Professor
Frequently Asked Questions
Who can join the NCT04530383 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Cystic Fibrosis-related Diabetes. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT04530383 trial and what does that mean for participants?
Phase 2 trials evaluate whether the treatment shows signs of effectiveness while continuing to monitor safety. More participants are enrolled than in Phase 1 to help refine the treatment protocol.
Is NCT04530383 currently recruiting?
Yes, NCT04530383 is actively recruiting participants. Contact the research team at msalathe@kumc.edu for enrollment information.
Where is the NCT04530383 trial being conducted?
This trial is being conducted at Kansas City, United States.
Who is sponsoring the NCT04530383 clinical trial?
NCT04530383 is sponsored by University of Kansas Medical Center. The principal investigator is Matthias A Salathe, M.D. at Professor. The trial plans to enroll 30 participants.
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