Effects of Metformin on Airway Ion Channel Dysfunction in Cystic Fibrosis-related Diabetes
Last updated on July 2021Recruitment
- Recruitment Status
- Not yet recruiting
Summary
- Conditions
- Cystic Fibrosis
- Cystic Fibrosis Related Diabetes
- Type
- Interventional
- Phase
- Phase 2
- Design
- Allocation: RandomizedIntervention Model: Crossover AssignmentMasking: Double (Participant, Investigator)Primary Purpose: Treatment
Participation Requirements
- Age
- Between 18 years and 125 years
- Gender
- Both males and females
Description
Up to 36 patients with CFRD on highly effective CFTR modulator therapy who meet criteria and agree to participation in the study will be placed on metformin 500 mg twice daily (low) and 1000 mg twice daily (normal) in a randomized order (simple randomization). There will be a dose-escalation with ea...
Up to 36 patients with CFRD on highly effective CFTR modulator therapy who meet criteria and agree to participation in the study will be placed on metformin 500 mg twice daily (low) and 1000 mg twice daily (normal) in a randomized order (simple randomization). There will be a dose-escalation with each dosing regimen starting with 500mg twice daily, followed by 1000mg in the AM and 500 mg in the PM and finally followed by 1000 mg twice daily (in those in the normal dose portion of the crossover trial). Participants will continue each dosing regimen of metformin for 14 weeks with a washout period of 2 weeks between dose changes.
Tracking Information
- NCT #
- NCT04530383
- Collaborators
- Not Provided
- Investigators
- Principal Investigator: Matthias A Salathe, M.D. Professor
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