An Open Label Clinical Trial of Metformin in Those With CFRD on CFTR Modulator Therapy to Improve Ion Channel Function
Who is this study for? Patients with cystic fibrosis-related diabetes
What treatments are being studied? Metformin Hydrochloride
Status: Recruiting
Location: See location...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 2
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
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:
• 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)
Locations
United States
Kansas
University of Kansas Medical Center
RECRUITING
Kansas City
Contact Information
Primary
Matthias A Salathe, M.D.
msalathe@kumc.edu
9135886000
Backup
Carolina Aguiar
caguiar@kumc.edu
9139459295
Time Frame
Start Date: 2022-02-14
Estimated Completion Date: 2028-07-15
Participants
Target number of participants: 30
Treatments
Experimental: Metformin dose regimen A
patients with CFRD on highly effective CFTR modulator therapy who meet criteria and agree to participation in the study will be placed on metformin. There will be a dose-escalation starting with 500mg twice daily for a week, followed by 500mg in the AM and 1000mg in the PM for another week and finally followed by 1000mg twice daily for 14 weeks.
Related Therapeutic Areas
Sponsors
Leads: University of Kansas Medical Center